Devices, systems and methods for treating benign prostatic hyperplasia and other conditions

ABSTRACT

Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

This application is a divisional of U.S. application Ser. No.11/134,870, filed May 20, 2005, which is expressly incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to devices, systems and methods for treatingconditions wherein a tissue (e.g., the prostate gland) has a) becomeenlarged and/or b) undergone a change in form, position, structure,rigidity or force exertion with respect to another anatomical structureand/or c) has begun to impinge upon or compress an adjacent anatomicalstructure (e.g., the urethra).

BACKGROUND OF THE INVENTION

There are numerous pathological and nonpathological conditions in whicha tissue (e.g., a gland, tumor, cyst, muscle, fascia, skin, adipose,mucous membrane, etc.) becomes enlarged, changed form or position and/orcauses unwanted impingement, obstruction, occlusion, stretching,sagging, caving, expulsion and/or collapse of an adjacent body lumen oranatomical structure (e.g., the urethra). Examples of specificconditions which illustrate these medical problems include tissuerelaxation or collapse (loose skin, fat or muscle folds, vaginal,rectal, or bladder prolapse, incontinence, etc.), tissue remodeling(scar formation, bladder stiffness secondary to chronic overexertion,infiltrative lung disease), traumatic injury, surgical manipulation(i.e. removal of supportive tissues, removal of tumors, reattachment ofligaments, etc.), tissue growth or enlargement (i.e. benign growths,cancers, angiomas, bone spurs, etc.), luminal obstruction or occlusion(coronary artery disease, peripheral vascular disease, stroke,non-communicating hydrocephalus, infertility secondary to non-patentfallopian tubes, urinary tract obstruction, etc.), tissue impingement(slipped spinal disks, degenerative joint disease, etc.), and ptosis.

In particular, Benign Prostatic Hyperplasia (BPH) is one of the mostcommon medical conditions that affect men, especially elderly men. Ithas been reported that, in the United States more than half of all menhave histopathologic evidence of BPH by age 60 and, by age 85,approximately 9 out of 10 men suffer from the condition. Moreover, theincidence and prevalence of BPH are expected to increase as the averageage of the population in developed countries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This compression of the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1a-adrenergic receptors blockersblock that activity of alpha-1a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1a-adrenergic receptorscauses prostatic smooth muscle relaxation. This in turn reduces urethralresistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todihydrotestosterone. Dihydrotestosterone causes growth of epithelialcells in the prostate gland. Thus 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and hence reducethe volume of the prostate gland which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethal Resection of Prostate (TURP) is the most commonly practicedsurgical procedure implemented for the treatment of BPH. In thisprocedure, prostatic urethral obstruction is reduced by removing most ofthe prostatic urethra and a sizeable volume of the surrounding prostategland. This is carried out under general or spinal anesthesia. In thisprocedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus the region of urethra that is blocked bythe surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases are deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam etc.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, aneodymium:yttrium-aluminum-garnet (Nd:YAG) laser is used to ablatetissue by causing coagulation necrosis. The procedure is performed undervisual guidance. In HoLEP, a holmium: Yttrium-aluminum-garnet laser isused for direct contact ablation of tissue. Both these techniques areused to remove tissue obstructing the urethral passage to reduce theseverity of BPH symptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is thePotassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser ishighly absorbed by oxyhemoglobin. This laser vaporizes cellular waterand hence is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate glandthus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned are at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which in turn causes the prostate gland toshrink. Shrinkage of the prostate gland reduces the degree of squeezingof the urethra by the prostate thus reducing the severity of BPHsymptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have significant disadvantages.Alpha-1a-adrenergic receptors blockers have side effects such asdizziness, postural hypotension, lightheadedness, asthenia and nasalstuffiness. Retrograde ejaculation can also occur. 5-alpha-reductaseinhibitors have minimal side effects, but only a modest effect on BPHsymptoms and the flow rate of urine. In addition, anti-androgens, suchas 5-alpha-reductase, require months of therapy before LUTS improvementsare observed. Surgical treatments of BPH carry a risk of complicationsincluding erectile dysfunction; retrograde ejaculation; urinaryincontinence; complications related to anesthesia; damage to the penisor urethra, need for a repeat surgery etc. Even TURP, which is the goldstandard in treatment of BPH, carries a high risk of complications.Adverse events associated with this procedure are reported to includeretrograde ejaculation (65% of patients), post-operative irritation(15%), erectile dysfunction (10%), need for transfusion (8%), bladderneck constriction (7%), infection (6%), significant hematuria (6%),acute urinary retention (5%), need for secondary procedure (5%), andincontinence (3%) Typical recovery from TURP involves several days ofinpatient hospital treatment with an indwelling urethral catheter,followed by several weeks in which obstructive symptoms are relieved butthere is pain or discomfort during micturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries have made their removal quite difficult andinvasive.

Thus the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

Thus there remains a need for the development of new devices, systemsand methods for treating BPH as well as other conditions in which onetissue or anatomical structure impinges upon or compresses anothertissue or anatomical structure.

SUMMARY OF THE INVENTION

The present invention provides devices, systems and methods forcompressing, cutting, incising, reconfiguring, remodeling, attaching,repositioning, supporting, dislocating or altering the composition oftissues or anatomical structures to alter their positional or forcerelationship to other tissues or anatomical structures. In someapplications, the invention may be used to improve patency or fluid flowthrough a body lumen or cavity. Examples of body lumens through whichflow may be facilitated using the present invention include the urethra,ureter, trachea, bronchus, bronchiole, other respiratory passageway,stomach, duodenum, small intestine, jejunum, illium, colon, cystic duct,hepatic duct, common bile duct, pancreatic duct, the alimentary canal,an endocrine passageway, a lymphatic, etc. Examples of tissues andanatomical structures that may be compressed, cut, incised,reconfigured, remodeled, attached, repositioned, supported, dislocatedor compositionally altered by the present invention include the prostategland, other glands and organs, neoplasms, benign growths, cancerousgrowths, tumors, cysts, other masses, congenital deformities, structuresthat have become enlarged due to hypertrophy, hyperplasia, edema, fluidbuild up, fluid retention, excess fluid production, impeded fluidoutflow, etc.

In accordance with the invention there are provided devices, systems andmethods for implanting devices within the body to compress tissue in amanner that relieves pressure exerted on or interference with anadjacent anatomical structure. The implantable devices useable for thispurpose generally comprising anchoring elements and tensioning elementsthat extend between the anchoring elements. The anchoring elements areimplanted at selected locations and the tensioning elements then draw orpull the anchoring elements toward one another, thereby compressingtissue between the anchoring elements. In applications where thesedevices are implanted to treat prostatic enlargement, anchoring andtensioning element(s) are implanted and tensioned to compress orreposition prostatic tissue thereby lessening prostate inducedconstriction of the urethra. In at least some applications, thisinvention may be used to treat prostatic enlargement without causingsubstantial damage to the urethra (e.g., forming an opening in theurethra no larger than about 2 mm in its greatest cross-dimension). Asused herein, the term “compress” includes not only actual compression ofthe tissue but also any application of pressure or force upon the tissuethat causes the intended therapeutic effect by reconfiguring,remodeling, repositioning or altering the tissue.

Still further in accordance with the invention there are provideddevices, systems and methods for cutting tissue(s) of the body in amanner that relieves pressure exerted on or interference with anadjacent anatomical structure. In some applications of the invention,one or more working devices may be inserted into the body and used toincise the capsule of an encapsulated organ, tumor, mass or otherstructure, thereby relieving the capsule's constraint of theencapsulated organ, tumor, mass or other structure and allowing theencapsulated organ, tumor, mass or other structure to expand, herniate,evulse, splay, spread apart, reconfigure or move in a way that resultsin decreased pressure on, or decreased interference with, the adjacentanatomical structure. In applications where the invention is used totreat prostatic enlargement, a cutting device may be anchoring andtensioning element(s) are implanted and tensioned to compress orreposition prostatic tissue thereby lessening prostate inducedconstriction of the urethra.

Additional and more specific aspects, elements, steps, applications,embodiments and examples of the invention will be understood by those ofskill in the art upon reading of the detailed description and claims setforth herebelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a sagittal sectional view of a male human body through thelower abdomen showing the male urinary tract.

FIG. 1B is a coronal sectional view through the lower abdomen of a humanmale showing a region of the male urogenital system.

FIG. 2A is a coronal sectional view through the prostate gland andadjacent structures showing a first trans-urethral approach that may beused to implant tissue compression devices(s) (e.g., clips, compressionelements, anchoring elements, etc.) to compress or modify the shape ofthe prostate gland.

FIG. 2B is a coronal sectional view through the prostate gland andadjacent structures showing a second trans-urethral approach that may beused to implant tissue compression devices(s) (e.g., clips, compressionelements, anchoring elements, etc.) to compress or modify the shape ofthe prostate gland.

FIG. 2C is a coronal sectional view through the prostate gland andadjacent structures showing a third trans-urethral approach that may beused to implant tissue compression devices(s) (e.g., clips, compressionelements, anchoring elements, etc.) to compress or modify the shape ofthe prostate gland.

FIG. 2D is a coronal sectional view through the prostate gland andadjacent structures showing a transperineal approach that may be used toimplant tissue compression devices(s) (e.g., clips, compressionelements, anchoring elements, etc.) to compress or modify the shape ofthe prostate gland.

FIG. 2E is a coronal sectional view through the prostate gland andadjacent structures showing a percutaneous approach that may be used toimplant tissue compression devices(s) (e.g., clips, compressionelements, anchoring elements, etc.) to compress or modify the shape ofthe prostate gland.

FIG. 2F is a coronal sectional view through the prostate gland andadjacent structures showing a percutaneous trans-osseus approach thatmay be used to implant tissue compression devices(s) (e.g., clips,compression elements, anchoring elements, etc.) to compress or modifythe shape of the prostate gland.

FIG. 2G is a coronal sectional view through the prostate gland andadjacent structures showing a percutaneous suprapubic approach that maybe used to implant tissue compression devices(s) (e.g., clips,compression elements, anchoring elements, etc.) to compress or modifythe shape of the prostate gland.

FIG. 2H is a sagittal sectional view through the prostate gland andadjacent structures showing a percutaneous infrapubic approach that maybe used to implant tissue compression devices(s) (e.g., clips,compression elements, anchoring elements, etc.) to compress or modifythe shape of the prostate gland.

FIG. 2I is a sagittal sectional view through the prostate gland andadjacent structures showing a trans-rectal approach that may be used toimplant tissue compression devices(s) (e.g., clips, compressionelements, anchoring elements, etc.) to compress or modify the shape ofthe prostate gland.

FIGS. 3A to 3H show various components of a system for treating prostategland disorders by compressing a region of the prostate gland. FIG. 3Ashows the perspective view of an introducer device.

FIG. 3B shows a perspective view of an injecting needle that may be usedfor injecting one or more diagnostic or therapeutic agents in theanatomy.

FIG. 3C shows a perspective view of an introducing sheath.

FIG. 3D shows a perspective view of a trocar.

FIG. 3E shows a perspective view of an anchor delivery device.

FIG. 3F shows an enlarged view of the distal region of the device inFIG. 3E.

FIG. 3G shows a perspective view of deployed anchors showing radiallyexpanded splayable arms of proximal anchor and distal anchor.

FIG. 3H shows a perspective view from the proximal direction of aparticular embodiment of the attachment mechanism of FIG. 99E.

FIGS. 4A through 4H show a coronal section through the prostate glandshowing the various steps of a method of treating prostate glanddisorders by compressing a region of the prostate gland using the kitshown in FIGS. 3A through 3H.

FIGS. 4G′ through 4H′ show the final steps of an embodiment of method oftreating prostate gland disorders by deploying a proximal anchor in theurethra.

FIG. 4H″ shows a coronal section through the prostate gland showing afinal deployed configuration of an embodiment of bone anchoring devicesfor treating prostate gland disorders by compressing a region of theprostate gland.

FIGS. 4I and 4J is a crossectional view through the prostatic urethra(i.e., the portion of the urethra that passes through the prostategland) showing the appearance of the urethral lumen before and afterperforming the method shown in FIGS. 4A through 4H.

FIGS. 5A through 5I show perspective views of some designs of thetension elements that can be used in the embodiments disclosed elsewherein this patent application.

FIG. 5A shows a perspective view of a tension element comprising asingle strand of an untwisted material.

FIG. 5B shows a perspective view of a tension element comprising one ormore serrations or notches.

FIG. 5C shows a perspective view of a tension element comprisingmultiple filaments of a material twisted together.

FIG. 5D shows a perspective view of a tension element comprising aflexible, elastic, spiral or spring element.

FIG. 5E shows a perspective view of a tension element comprising a screwthreading on the outer surface of tension element.

FIG. 5F shows a perspective view of a tension element comprising ahollow shaft comprising one or more collapsible regions.

FIG. 5G shows a perspective view of an anchoring device 522 comprising atension element and two anchors.

FIG. 5H shows a perspective view of a tensioning element devicecomprising a detachable region.

FIG. 5I shows a perspective view of a tensioning element comprisingtelescoping tubes.

FIGS. 6A through 11B show various examples of anchor designs and/oranchoring device designs.

FIGS. 6A and 6B show perspective views of two states of a crumplinganchor.

FIGS. 7A and 7B show sectional views of an undeployed configuration anda deployed configuration respectively of a deployable anchor.

FIGS. 8A and 8B show sectional views of an undeployed configuration anda deployed configuration respectively of a “T” shaped deployable anchor.

FIGS. 9A through 9D show various alternate configurations of theanchoring arms in FIGS. 7A and 7B.

FIGS. 10A and 10A′ show a distal view and a perspective viewrespectively of an anchor comprising a spiral element having a threedimensional shape.

FIGS. 10B and 10B′ show a distal view and a side view respectively of ananchor comprising a spiral element having a two dimensional shape.

FIGS. 10C and 10C′ show a distal view and a perspective viewrespectively of an anchor comprising one or more circular elements.

FIG. 10D shows a perspective view of an embodiment of an anchoringdevice comprising an outer ring.

FIG. 10E shows a partial perspective view of an anchoring devicecomprising a hemostatic element.

FIG. 11A shows a perspective view of a device having a set of anchorscomprising a curved sheet.

FIGS. 12A through 17I show further examples of anchor designs and/oranchoring device designs. FIG. 12A shows a perspective view of an anchorcomprising an arrowhead.

FIG. 12B shows a crossectional view of an anchor comprising a cup-shapedelement that encloses a cavity.

FIG. 12C shows a perspective view of an anchor comprising a screw.

FIGS. 13A and 13B show perspective views of an uncollapsed state and acollapsed state respectively of an anchor comprising a collapsibleregion.

FIGS. 13C and 13D show perspective views of an undeployed state and adeployed state respectively of an anchor comprising radially spreadingarms.

FIG. 13E shows perspective views of an alternate embodiment of anundeployed state of an anchor comprising radially spreading arms.

FIGS. 14A and 14B show perspective views of anchoring devices comprisingan adhesive delivering element.

FIGS. 15A and 15B show two configurations of an anchoring devicecomprising a ratcheted tension element.

FIG. 16 shows a perspective view of an anchor comprising a trocar lumen.

FIG. 17A shows a perspective view in the undeployed state of an anchorcomprising a rigid or partially flexible T element and a crumplingelement.

FIGS. 17B and 17C show various steps of a method to deploy the anchoringdevice shown in FIG. 17A.

FIGS. 17D, 17E and 17E′ show perspective views and a cross-sectionalview of an anchor comprising a rigid or partially flexible T elementwith one or more openings or perforations.

FIGS. 17F and 17G show perspective views of an undeployed and deployedconfiguration of an anchor comprising a stent.

FIGS. 17H and 17I show perspective views of an undeployed and deployedconfiguration of an anchor comprising a spring.

FIGS. 18A through 22E show various embodiments of mechanisms to deployone or more anchors. FIGS. 18A and 18B show a crossection of an anchordeploying mechanism comprising a screw system.

FIGS. 19A and 19B show a crossectional view of an anchor deployingsystem comprising an electrolytic detachment element.

FIG. 20 shows a perspective view of an anchor deploying systemcomprising a looped ribbon.

FIG. 21A shows a crossectional view of an anchor deploying systemcomprising a locked ball.

FIGS. 21B and 21C show a method of deploying an anchor comprising alocked ball.

FIGS. 22A through 22C show various views of an anchor deploying systemcomprising two interlocking cylinders.

FIGS. 22D and 22E show the steps of a method of unlocking the twointerlocking cylinders from the anchor deploying systems of FIGS. 22Athrough 22C.

FIG. 23A shows a perspective view of a distal end of an anchoring devicethat has an imaging modality.

FIGS. 23B through 23G show various steps of a method for compressing ananatomical region using the anchoring device of FIG. 23A.

FIGS. 24A through 24C′ show the device and various steps of a method ofcompressing an anatomical region using a device with deploying armsdeployed through a trocar.

FIG. 24D shows a crossection through the deployed anchoring device ofFIG. 24A.

FIG. 25A shows a perspective view of a spring clip that can be used tospread the anatomy.

FIGS. 25B through 25F show various steps of a method of spreading ananatomical region or regions using the spring clip of FIG. 25A.

FIGS. 26A and 26B show a crossectional view and a perspective viewrespectively of a mechanism of cinching a tension element or tether toan anchor.

FIGS. 26C and 26D show a partial section through a cinching mechanismcomprising a cam element.

FIG. 26E shows a sectional view of an embodiment of a cinching mechanismcomprising a locking ball.

FIG. 26F shows a side view of an embodiment of a cinching mechanismcomprising multiple locking flanges.

FIG. 26G shows an end view of body of FIG. 26F.

FIG. 26H shows a side view of an embodiment of a cinching mechanismcomprising a single locking flange.

FIG. 26I shows an end view of body of FIG. 26H.

FIG. 26J shows an end view of a cinching mechanism comprising a crimpinglumen.

FIGS. 26K and 26L show crossections of an embodiment of a cinchingmechanism comprising a crimping anchor in the undeployed and deployedconfigurations respectively.

FIG. 26M shows a perspective view of an embodiment of a cinchingmechanism comprising an element providing a tortuous path to a tensionelement.

FIG. 26N shows a crossectional view of an embodiment of a lockingmechanism comprising a space occupying anchor securely attached to atension element.

FIGS. 26O and 26P shows a partial sectional view and a perspective viewof an embodiment of a cinching mechanism comprising a punched disk.

FIGS. 26Q and 26R show a perspective view of a first embodiment of acutting device before and after cutting an elongate element.

FIG. 26S show a crossectional view of a second embodiment of a cuttingdevice for cutting an elongate element.

FIGS. 27A through 27D show axial sections through the prostate glandshowing various configurations of anchoring devices comprising distalanchors and a tension element.

FIGS. 28 and 28A show perspective views of an embodiment of an anchoringdevice comprising an elongate element comprising multiple barbs oranchors.

FIGS. 28B through 28E show a coronal section through the prostate glandshowing various steps of a method of treating the prostate gland usingthe device of FIG. 28.

FIG. 29A shows an axial section of the prostate gland showing a pair ofimplanted magnetic anchors.

FIGS. 29B through 29D show a coronal section through the prostate glandshowing the steps of a method of implanting magnetic anchors of FIG.29A.

FIG. 30A is a coronal sectional view of a portion of the male urogenitalsystem showing a transurethral approach that may be used to perform aprostate cutting procedure of the present invention.

FIG. 30B is a coronal sectional view of a portion of the male urogenitalsystem showing another transurethral approach that may be used toperform a prostate cutting procedure of the present invention.

FIG. 30C is a coronal sectional view of a portion of the male urogenitalsystem showing a transurethral/transvesicular approach that may be usedto perform a prostate cutting procedure of the present invention.

FIG. 30D is a coronal sectional view of a portion of the male urogenitalsystem showing another transurethral approach that may be used toperform a prostate cutting procedure of the present invention, wherein adevice advances from the urethra, through the prostate gland, andthereafter accesses the prostate capsule from its outer surface.

FIG. 31 is a coronal sectional view of a portion of the male urogenitalsystem showing a percutaneous/infrapubic approach that may be used toperform a prostate cutting procedure of the present invention.

FIG. 32 is a coronal sectional view of a portion of the male urogenitalsystem showing a percutaneous/transvesicular approach that may be usedto perform a prostate cutting procedure of the present invention.

FIGS. 33A-33E shows perspective views of various devices that may beincluded in a system for performing a prostate cutting procedure inaccordance with the present invention.

FIG. 33A shows a perspective view of an introducer device comprising afirst tubular element having a working device lumen.

FIG. 33B shows a perspective view of an injecting needle that may beused for injecting one or more diagnostic or therapeutic substances.

FIG. 33C shows a perspective view of a guiding device comprising anelongate body comprising a sharp distal tip.

FIG. 33D shows a perspective view of a RF cutting device

FIG. 33E shows a perspective view of an embodiment of a plugging deviceto plug an opening created during a procedure.

FIGS. 33F through 33N show various alternate embodiments of theelectrosurgical cutting device in FIG. 33D.

FIGS. 33F and 33G show perspective views of the distal region of a firstalternate embodiment of an electrosurgical cutting device in theundeployed and deployed states respectively.

FIGS. 33H and 33I show perspective views of the distal region of asecond alternate embodiment of an electrosurgical cutting device in theundeployed and deployed states respectively.

FIGS. 33J through 33L show perspective views of the distal region of asecond alternate embodiment of an electrosurgical cutting device showingthe steps of deploying the electrosurgical cutting device.

FIGS. 33M through 33N show perspective views of the distal region of athird alternate embodiment of an electrosurgical cutting device showingthe steps of deploying the electrosurgical cutting device.

FIG. 34 shows a perspective view of the distal region of a ballooncatheter comprising a balloon with cutting blades.

FIG. 35 shows a perspective view of the distal region of a ballooncatheter comprising a balloon with cutting wires.

FIGS. 36A and 36B series show perspective views of an undeployed stateand a deployed state respectively of a tissue displacement device.

FIGS. 36C and 36D show a coronal view and a lateral view respectively ofa pair of deployed tissue displacement devices of FIGS. 36A and 36Bimplanted in the prostate gland.

FIGS. 36E through 36H show an axial section through a prostate glandshowing the various steps of a method of cutting or puncturing theprostate gland and lining or plugging the cut or puncture.

FIGS. 37A through 37K show an embodiment of a method of treatingprostate gland disorders by cutting a region of the prostate gland usingthe devices described in FIG. 33A through 33E.

FIGS. 38A to 38D show various components of a kit for treating prostategland disorders by compressing a region of the prostate gland. FIG. 38Ashows the perspective view of an introducer device.

FIG. 38B shows a perspective view of a bridge device

FIG. 38C shows a perspective view of a distal anchor deployment device

FIG. 38D shows the proximal anchor delivery tool

FIG. 38E shows a close-up perspective view of proximal anchor 3833mounted on proximal anchor delivery tool of FIG. 38D.

DETAILED DESCRIPTION

The following detailed description and the accompanying drawings areintended to describe some, but not necessarily all, examples orembodiments of the invention only and does not limit the scope of theinvention in any way.

The following detailed description and the accompanying drawings areintended to describe some, but not necessarily all, examples orembodiments of the invention only and does not limit the scope of theinvention in any way.

A number of the drawings in this patent application show anatomicalstructures of the male reproductive and/or urinary system. In general,these anatomical structures are labeled with the following referenceletters:

Urethra UT Urethral Lumen UL Urethral Opening UO Urinary Bladder UBUreters UR Prostate Gland PG Capsule of Prostate Gland CP Testis TS VasDeferens VD

FIG. 1A shows a sagittal section of a male human body through the lowerabdomen showing the male urinary tract. The male urinary tract comprisesa pair of tubular organs called ureters (UR) that conduct urine producedby the kidneys. The ureters empty into the urinary bladder. The urinarybladder is a hollow muscular organ that temporarily stores urine. It issituated posterior to the pubic bone. The inferior region of the urinarybladder has a narrow muscular opening called the bladder neck whichopens into a soft, flexible, tubular organ called the urethra. Themuscles around the bladder neck are called the internal urethralsphincter. The internal urethral sphincter is normally contracted toprevent urine leakage. The urinary bladder gradually fills with urineuntil full capacity is reached, at which point the sphincter relaxes.This causes the bladder neck to open, thereby releasing the urine storedin the urinary bladder into the urethra. The urethra begins at thebladder neck, terminates at the end of the penis, and allows for urineto exit the body.

The region of the urethra just inferior to the urinary bladder iscompletely surrounded by the prostate gland. The prostate gland is partof the male reproductive system and is usually walnut shaped.Clinically, the prostate is divided into lobes. The lateral lobes arelocated lateral to the urethra; the middle lobe is located on the dorsalaspect of the urethra, near the bladder neck. Most commonly in BPH, thelateral lobes become enlarged and act like curtains to close theurethral conduit. Less commonly, the middle lobe grows in size andbecomes problematic. Because of its superior location near the bladderneck with respect to the urethra, an enlarged middle lobe acts like aball valve and occludes fluid passage.

FIG. 1B shows a coronal section through the lower abdomen of a humanmale showing a region of the male urinary system. The prostate gland(PG) is located around the urethra at the union of the urethra and theurinary bladder.

FIGS. 2A through 2H show various alternate approaches to deployimplantable tissue compression device(s) (e.g., one or more clips,anchoring elements, tensioning members, etc.) to compress the prostategland PG, thereby relieving constriction of the urethra. Specificexamples of implantable tissue compression device(s) (e.g., one or moreclips, anchoring elements, tensioning members, etc.) useable in thisinvention are shown in other figures of this patent application and aredescribed more fully herebelow.

FIG. 2A shows a first trans-urethral approach that may be used toimplant tissue compression devices(s) to compress the prostate gland PG.In FIG. 2A, an introducing device 200 is introduced in the urethrathrough the urethral opening of the penis. Introducing device 200comprises an elongate body 202 comprising a lumen that terminatesdistally in a distal opening 204. One or more working device(s) 206is/are then introduced through distal opening 204 into the urethra. Theworking device(s) 206 penetrate the urethral wall and thereafter one ormore lobes of the prostate gland. In some applications of the method,working device(s) 206 may further penetrate the prostate capsule andenters the pelvic cavity. Working device(s) 206 are also used to deployand implant implantable tissue compression device(s) (e.g., one or moreclips, anchoring elements, tensioning members, etc.) to compress theprostate gland PG, thereby relieving constriction of the urethra.

FIG. 2B shows a second trans-urethral approach that may be used toimplant tissue compression devices(s) to compress the prostate gland PG.In FIG. 2B, an introducing device 210 is introduced in the urethrathrough the urethral opening UO of the penis. Introducing device 210comprises an elongate body 212 comprising a lumen that terminatesdistally in a distal opening 214. One or more working device(s) 216is/are insertable through distal opening 214 into the urethra. Workingdevice(s) 216 penetrate(s) the urethral wall inferior to the prostategland and enters the pelvic cavity. Thereafter, working device(s) 216penetrate(s) the prostate capsule CP and thereafter one or more lobes ofthe prostate gland. In some applications of the method the workingdevice(s) 216 may further penetrate the urethral wall enclosed by theprostate gland EG and enters the urethral lumen. Working device(s) 216may then be used to deploy and implant implantable tissue compressiondevice(s) (e.g., one or more clips, anchoring elements, tensioningmembers, etc.) to compress the prostate gland PG, thereby relievingconstriction of the urethra.

FIG. 2C shows a third trans-urethral approach that may be used toimplant tissue compression devices(s) to compress the prostate gland PG.In FIG. 2C, an introducing device 220 is introduced in the urethrathrough the urethral opening UO of the penis. Introducing device 220comprises an elongate body 222 comprising a lumen that terminatesdistally in a distal opening 224. Introducing device 220 is positionedsuch that distal opening 224 is located in the urinary bladder UB.Thereafter, a one or more working device(s) 226 is/are introducedthrough distal opening 224 into the urinary bladder UB. Workingdevice(s) 226 penetrate(s) the wall of the urinary bladder UB andthereafter penetrate(s) one or more lobes of the prostate gland PG. Insome applications of the method, the working device(s) 226 may furtherpenetrate the prostate capsule and enter the pelvic cavity. Workingdevice(s) 226 may then be used to deploy and implant implantable tissuecompression device(s) (e.g., one or more clips, anchoring elements,tensioning members, etc.) to compress the prostate gland PG, therebyrelieving constriction of the urethra.

FIG. 2D shows a transperineal approach that may be used to implanttissue compression devices(s) to compress the prostate gland PG. In FIG.2D, an introducing device 230 is introduced in the pelvic cavitypercutaneously through the perineum. Introducing device 230 comprises anelongate body 232 comprising a lumen that terminates distally in adistal opening 234. Introducing device 230 is positioned such thatdistal opening 234 is located in the pelvic cavity adjacent to prostategland. Thereafter, one or more working device(s) 236 is/are introducedthrough distal opening 234 into the prostate gland PG. Working device(s)236 penetrate(s) the prostate capsule CP and thereafter penetrate(s) oneor more lobes of the prostate gland PG. In some applications of themethod, the working device(s) 236 may further penetrate the urethralwall surrounded by the prostate gland PG and enter the urethral lumen.Working device 236 may then be used to deploy and implant implantabletissue compression device(s) (e.g., one or more clips, anchoringelements, tensioning members, etc.) to compress the prostate gland PG,thereby relieving constriction of the urethra.

FIG. 2E shows a percutaneous/transvesicular approach that may be used toimplant tissue compression devices(s) to compress the prostate gland PG.In FIG. 2E, an introducing device 240 is introduced percutaneouslythrough the abdominal wall. Introducing device 240 comprises an elongatebody 242 comprising a lumen that terminates distally in a distal opening244. After passing through the abdominal wall, introducing device 240 isadvanced through the wall of the urinary bladder UB such that distalopening 244 is located in the urinary bladder UB. Thereafter, one ormore working device(s) 246 is/are introduced through distal opening 244into the urinary bladder UB. One or more working device(s) 246 areadvanced through the wall of the urinary bladder UB and into theprostate gland PG. In some applications of the method, working device(s)246 may further penetrate through the prostate gland capsule and enterthe pelvic cavity. Working device(s) 246 is/are then used to deploy andimplant implantable tissue compression device(s) (e.g., one or moreclips, anchoring elements, tensioning members, etc.) to compress theprostate gland PG, thereby relieving constriction of the urethra.

FIG. 2F shows a percutaneous trans-osseus approach that may be used toimplant tissue compression devices(s) to compress the prostate gland PG.In FIG. 2F, an introducing device 250 is introduced percutaneouslythrough the abdominal wall. Introducing device 250 comprises an elongatebody 252 comprising a lumen that terminates distally in a distal opening254. Introducing device 250 is used to penetrate a pelvic bone (e.g. thepubic bone PB). Thereafter, introducing device 250 is positioned suchthat distal opening 254 is located adjacent to the prostate gland PG.Thereafter, one or more working device(s) 256 is/are introduced throughdistal opening 254 into the prostate gland PG. Working device(s) 256penetrate the prostate capsule and thereafter penetrate one or morelobes of the prostate gland PG. In some applications of the method,working device(s) 256 may further penetrate the urethral wall surroundedby the prostate gland and enter the urethral lumen. Working device(s)256 is/are then used to deploy and implant implantable tissuecompression device(s) (e.g., one or more clips, anchoring elements,tensioning members, etc.) to compress the prostate gland PG, therebyrelieving constriction of the urethra.

FIG. 2G shows a percutaneous suprapubic approach that may be used toimplant tissue compression devices(s) to compress the prostate gland PG.In FIG. 2G, an introducing device 260 is introduced in the pelvic cavitypercutaneously in a trajectory that passes superior to the pubis bone.Introducing device 260 comprises an elongate body 262 comprising a lumenthat terminates distally in a distal opening 264. Introducing device 260is then positioned such that distal opening 264 is located in the pelviccavity adjacent to prostate gland. Thereafter, one or more workingdevice(s) 266 is/are introduced through distal opening 264 into theprostate gland PG. Working device(s) 266 penetrate the prostate capsuleCP and thereafter penetrate one or more lobes of the prostate gland PG.In some applications of the method, working device(s) 266 may furtherpenetrate the urethral wall surrounded by the prostate gland and enterthe urethral lumen. Working device(s) 266 is/are then used to deploy andimplant implantable tissue compression device(s) (e.g., one or moreclips, anchoring elements, tensioning members, etc.) to compress theprostate gland PG, thereby relieving constriction of the urethra. FIG.2H shows a percutaneous infrapubic approach that may be used to implanttissue compression devices(s) to compress the prostate gland. In FIG.2H, an introducing device 270 is introduced in the pelvic cavitypercutaneously in a trajectory that passes inferior to the pubis bone.Introducing device 270 comprises an elongate body 272 comprising a lumenthat terminates distally in a distal opening 274. Introducing device 270is introduced percutaneously in the pelvic cavity in a trajectory thatpasses inferior to the pubic bone. Introducing device 270 is thenpositioned such that distal opening 274 is located in the pelvic cavityadjacent to prostate gland. Thereafter, one or more working device(s)276 is/are introduced through distal opening 274 into the prostate glandPG. Working device(s) 276 penetrate the prostate capsule CP andthereafter penetrate one or more lobes of the prostate gland PG. In someapplications of the method, working device(s) 276 may further penetratethe urethral wall surrounded by the prostate gland PG and enter theurethral lumen. Working device(s) 276 is/are then used to deploy andimplant implantable tissue compression device(s) (e.g., one or moreclips, anchoring elements, tensioning members, etc.) to compress theprostate gland PG, thereby relieving constriction of the urethra.

FIG. 2I shows a trans-rectal approach that may be used to implant tissuecompression devices(s) to compress the prostate gland PG. In FIG. 2I, anintroducing device 280 is introduced in the rectum. Introducing device280 comprises an elongate body 282 comprising a lumen that terminatesdistally in a distal opening 284. Introducing device is then advancedsuch that it penetrates the rectal wall and enters the pelvic cavity.Introducing device 280 is then positioned such that distal opening 284is located in the pelvic cavity adjacent to prostate gland. Thereafter,one or more working device(s) 286 is/are introduced through distalopening 284 into the prostate gland PG. Working device(s) 286 penetratethe prostate capsule CP and thereafter penetrate one or more lobes ofthe prostate gland. In some applications of the method, workingdevice(s) 286 may further penetrate the urethral wall surrounded by theprostate gland and enter the urethral lumen. Working device(s) 286is/are then used to deploy and implant implantable tissue compressiondevice(s) (e.g., one or more clips, anchoring elements, tensioningmembers, etc.) to compress the prostate gland PG, thereby relievingconstriction of the urethra.

FIGS. 3A to 3F show various examples of devices and systems that areuseable to treat conditions where the prostate gland PG is compressing aregion of the urethra such that the urethra does not expand normallyduring micturition and urine outflow is impeded.

FIG. 3A shows the perspective view of an introducer device 300.Introducer device 300 comprises an outer body 301 constructed fromsuitable biocompatible materials including, but not limited to Pebax,Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE,PEEK, metals like stainless steel and fluoropolymers like PTFE, PFA,FEP, EPTFE etc. Body 301 comprises a working device lumen 302. Distalend of working device lumen 302 emerges out of the distal end of body301. In one embodiment, distal end of working device lumen 302 has abent or curved region. Proximal end of working device lumen 302 emergesout of a first flexible tube 304. The proximal end of first flexibletube 304 comprises a stasis valve 306. Body 301 further comprises acystoscope lumen 308. Distal end of cystoscope lumen 308 emerges out ofthe distal end of body 301. Proximal end of cystoscope lumen 308 emergesout of a second flexible tube 310. The proximal end of second flexibletube 310 comprises a stasis valve 312. Cystoscope lumen 308 may compriseone or more side ports e.g. a first side port 318 for the introductionor removal of one or more fluids. Working device lumen 302 may compriseone or more side ports e.g. a second side port 320 for the introductionor removal of one or more fluids.

FIG. 3B shows a perspective view of an injecting needle. Injectingneedle 330 is used for injecting one or more diagnostic or therapeuticsubstances. In some applications of the invention, the injecting needle330 may be used to inject local anesthetic in the urethra, prostategland and/or tissues near the prostate gland. Specific examples oftarget areas for injecting local anesthetics are the neurovascularbundles, the genitourinary diaphragm, the region between the rectal walland prostate, etc. Examples of local anesthetics that can be injected byinjecting needle 330 are anesthetic solutions e.g. 1% lidocainesolution; anesthetic gels e.g. lidocaine gels; combination of anestheticagents e.g. combination of lidocaine and bupivacaine; etc. Injectingneedle 330 comprises a hollow shaft 332 made of suitable biocompatiblematerials including, but not limited to stainless steel 304, stainlesssteel 306, Nickel-Titanium alloys, titanium etc. In this example, thedistal end of hollow shaft 332 comprises a sharp tip 334. The proximalend of hollow shaft 332 has a needle hub 336 made of suitablebiocompatible materials including, but not limited to metals e.g.stainless steel 304, stainless steel 306, Nickel-Titanium alloys,titanium etc.; polymers e.g. polypropylene, Pebax, Polyimide, BraidedPolyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP,EPTFE etc. In one embodiment, needle hub 336 comprises a luer lock.

FIG. 3C shows an example of an introducing device or introducing sheath340. Introducing sheath 340 comprises a hollow, tubular body 342 made ofsuitable biocompatible materials including, but not limited to metalse.g. stainless steel 304, stainless steel 306, Nickel-Titanium alloys,titanium etc. or polymers e.g. Pebax, Polyimide, Braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc.Tubular body 342 further comprises two marker bands: a proximal markerband 344 and a distal marker band 346. The marker bands can be seen by acystoscope. In one embodiment, proximal marker band 344 and distalmarker band 346 are radiopaque. The position of proximal marker band 344and distal marker band 346 is such that after introducing sheath 340 isplaced in an optimum location in the anatomy, proximal marker band 344is located in the urethra where it can be seen by a cystoscope anddistal marker band 346 is located in the prostate gland or in the wallof the urethra where it cannot be seen by a cystoscope. Tubular body 342further comprises a series of distance markers 348 on the outer surfaceof tubular body 342. The proximal end of tubular body 342 furthercomprises a hub 350 made of suitable biocompatible materials including,but not limited to metals e.g. stainless steel 304, stainless steel 306,Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax, Polyimide,Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE,PFA, FEP, EPTFE etc. In one embodiment, hub 350 comprises a luer lock.

FIG. 3D shows a perspective view of a trocar. Trocar 360 comprises atubular trocar body 362. The proximal end of trocar body 362 comprises ahub 364. Trocar body 362 and hub can be constructed from suitablebiocompatible materials including, but not limited to metals e.g.stainless steel 304, stainless steel 306, Nickel-Titanium alloys,titanium etc. or polymers e.g. Pebax, Polyimide, Braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE etc.Distal end of trocar body 362 ends in a sharp trocar tip 366.

FIG. 3E shows a perspective view of an anchor delivery device. Anchordelivery device 370 comprises a body 372 having a distal opening 373. Asection of the distal region of body 372 has been removed to show a viewof the anchor assembly. Body 372 encloses a distal anchor 374 and aproximal anchor 376. Proximal anchor 376 and distal anchor 374 can havea variety of designs including, but not limited to the designs disclosedelsewhere in this patent application. Proximal anchor 376 and distalanchor 374 can be constructed from suitable biocompatible materialsincluding, but not limited to metals e.g. stainless steel 304, stainlesssteel 306, Nickel-Titanium alloys, titanium etc. or polymers e.g. Pebax,Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE,PEEK, PTFE, PFA, FEP, EPTFE etc. In one embodiment, shown in FIGS. 3Fand 3G, proximal anchor 9976 and distal anchor 9974 comprise splayableelements that expand in a radially outward direction when a radialcompression force, as enacted by body lumen 9972, on proximal anchor9976 and distal anchor 9974 is removed. The splayable elements can bemade of suitable super-elastic materials such as Nickel-Titanium alloysetc. Proximal anchor 9976 and distal anchor 9974 are connected to eachother by a tension element 9978. Tension element 9978 can be made ofsuitable elastic or non-elastic materials including, but not limited tometals e.g. stainless steel 304, stainless steel 306, Nickel-Titaniumalloys, suture materials, titanium etc. or polymers such as silicone,nylon, polyamide, polyglycolic acid, polypropylene, Pebax, PTFE, ePTFE,silk, gut, or any other braided or mono-filament material. Tensionelement 9978 can have a variety of designs including the designs shownin FIGS. 5A through 5F. As shown in FIG. 3E, the proximal end ofproximal anchor 9976 is connected by an attachment mechanism 9980 to atorquable shaft 9982. The proximal end of torquable shaft 9982 isattached to a control button 9984. Control button 9984 can be used todeploy proximal anchor 9976 by sliding control button 9984 along groove9985 in the distal direction. Control button 9984 is then used to deploydistal anchor 9974 by turning control button 9984 in the circumferentialdirection along groove 9985.

FIG. 3H shows a perspective view from the proximal direction of aparticular embodiment of the attachment mechanism of FIG. 3E. Attachmentmechanism 380 comprises a circular plate 386 made from suitablebiocompatible materials including, but not limited to metals e.g.stainless steel 304, stainless steel 306, Nickel-Titanium alloys,titanium etc. or polymers e.g. Polycarbonate, PVC, Pebax, Polyimide,Polyurethane, Nylon, Hytrel, HDPE, PEEK, PTFE, PFA, FEP etc. Theproximal face of circular plate 386 is connected to torquable shaft 382.Circular plate 386 further comprises a semicircular groove 388. One endof semicircular groove 388 comprises an enlarged region 390. A knob 392located on the proximal portion of proximal anchor 376 slides onsemicircular groove 388. The size of knob 322 is larger than the size ofsemicircular groove 388 but smaller than size of enlarged region 390.This keeps proximal anchor 376 attached to circular plate 386. Whencontrol button 384 is turned in the circumferential direction alonggroove 385, torquable shaft 382 is turned. This turns circular plate 386causing knob 392 to slide on the groove 388. Ultimately, knob 392reaches enlarged region 390. This releases knob 392 from circular plate386 thereby releasing proximal anchor 376 from anchor delivery device370.

FIGS. 4A through 4H show a coronal section through the prostate glandshowing the various steps of a method of treating prostate glanddisorders by compressing a region of the prostate gland using the kitshown in FIGS. 3A through 3F. In FIG. 4A, introducer device 300 isintroduced in the urethra through the urethral opening at the tip if thepenis. A cystoscope is inserted in introducer device 300 throughcystoscope lumen 308 such that the lens of the cystoscope is located inthe distal opening of cystoscope lumen. The cystoscope is used tonavigate introducer device 300 through the urethra such that the distalregion of introducer device 300 is located in a target region in theprostatic urethra. Thereafter in FIG. 4B, injecting needle 330 isadvanced through working device lumen 302 such that the distal tip ofinjecting needle 330 penetrates into a region of the urethral wall orthe prostate gland. Injecting needle 330 is then used to inject one ormore diagnostic or therapeutic agents into the urethral wall or theprostate gland. This step may be repeated one or more times to injectone or more diagnostic or therapeutic agents in one or more regions ofthe urethral wall and/or the prostate gland. In one method embodiment,injecting needle 330 is used to inject an anesthetic in one or moreregions of the urethral wall and/or the prostate gland. In anotherembodiment, injecting needle 330 is used to deliver energy in the formof radiofrequency energy, resistive heating, laser energy, microwaveenergy etc. In another embodiment, injecting needle 330 is used todeliver alpha antagonist agents, such as phenoxybenzamine, prazosin,doxazosin, terazosin, tamsulosin, alfuzosin etc. In another embodiment,injecting needle 330 is used to deliver anti-androgen, such as flutamideor 5-alpha reductase inhibitors, such as finasteride, dutasteride,3-oxosteroid compounds, 4-aza-3-oxosteroid derivatives of testosteroneetc. In another embodiment, injecting needle 330 is used to deliveranti-inflammatory agents, such as rapamycin, paclitaxel, ABT-578,everolimus, taxol etc. In another embodiment, injecting needle 330 isused to deliver ablative agents such as methyl alcohol etc.

In another embodiment, injecting needle 330 is used to deliver energy inthe form of radiofrequency energy, resistive heating, laser energy,microwave energy etc. In another embodiment, injecting needle 330 isused to deliver alpha antagonist agents, such as phenoxybenzamine,prazosin, doxazosin, terazosin, tamsulosin, alfuzosin etc. In anotherembodiment, injecting needle 330 is used to deliver anti-androgen, suchas flutamide or 5-alpha reductase inhibitors, such as finasteride,dutasteride, 3-oxosteroid compounds, 4-aza-3-oxosteroid derivatives oftestosterone etc. In another embodiment, injecting needle 330 is used todeliver anti-inflammatory agents, such as rapamycin, paclitaxel,ABT-578, everolimus, taxol etc. In another embodiment, injecting needle330 is used to deliver ablative agents such as methyl alcohol etc.

In step 4C, injecting needle 330 is withdrawn from introducer device300. Thereafter, introducer sheath 340 and trocar 360 are advancedthrough working device lumen 302. In the example shown, introducersheath 340 and trocar 360 are advanced till the distal tip of trocar 360penetrates the capsule of the prostate gland and the distal end ofintroducer sheath 340 is located outside the prostate gland in thepelvic cavity. Thereafter, trocar 360 is withdrawn from working devicelumen 302 leaving introducer sheath 340 in place. In FIG. 4D, anchordelivery device 370 is introduced through the lumen of introducer sheath340 till the distal end of body 372 protrudes through the distal tip ofintroducer sheath 340. In step 4E, distal anchor 374 is deployed. Itshould be noted that the anchor may be carried to the site and deployedfrom within an introducer, on the outside of an introducer, or it may bethe distal tip of the introducer itself. Thereafter, anchor deliverdevice 370 is pulled in the proximal direction along with introducersheath 340 so that distal anchor 374 is anchored on the outer surface ofthe prostate capsule. This step may be used to create tension in thetension element 378. In one method embodiment, anchor deliver device 370is pulled in the proximal direction along with introducer sheath 340such that the distal end of anchor delivery device 370 is located in theprostate gland. In another method embodiment, anchor deliver device 370is pulled in the proximal direction along with introducer sheath 340till the distal end of anchor delivery device 370 is located in theurethral wall or the urethral lumen. In step 4F, proximal anchor 376 isdeployed. Proximal anchor 376 may be deployed in the prostate gland, inthe urethral wall or in the urethral lumen. Proximal anchor 376 is stillattached by attachment mechanism 380 to anchor delivery device 370. Theproximal anchor may be pre-loaded on the tension element, or maysubsequently be loaded by the operator on the tension element. FIGS. 4Gthrough 4H show the steps of deploying proximal anchor 376 in theprostate gland. In FIG. 4G, proximal anchor 376 is separated from anchordelivery device 370. This separation may be achieved via numerous meansincluding cutting, melting, un-locking a link, or breaking thetensioning element at a desired location. Ideally this residual end ofthe tensioning element will not protrude substantially into the lumen ofthe urethra. Thus proximal anchor 376 and distal anchor 374 are anchoredin the anatomy. Thereafter, anchor delivery device 370 and introducersheath 340 are both pulled in the proximal direction and are withdrawninto introducer device 300. Thereafter, introducer device 300 is pulledin the proximal direction to pull it out of the urethra. In FIG. 4H, thesteps from FIG. 4A through 4G are repeated in a second region of theprostate gland if desired to implant two or more sets of anchoringdevices.

Alternatively, FIGS. 4G′ through 4H′ show the steps of deployingproximal anchor 376 in the urethra. After the step in FIG. 4F, in FIG.4G′, proximal anchor 376 is separated from anchor delivery device 370 inthe urethra. Thus proximal anchor 376 and distal anchor 374 are anchoredin the urethra and the prostate capsule respectively. Thereafter, anchordelivery device 370 and introducer sheath 340 are both pulled in theproximal direction and are withdrawn into introducer device 300.Thereafter, introducer device 300 is pulled in the proximal direction topull it out of the urethra. In FIG. 4H′, the steps from FIG. 4A through4G′ are repeated optionally in a second region of the prostate gland toimplant two or more sets of anchoring devices. It should be understoodthat this method and devices may be applied to any lobe (middle orlateral lobes) of the prostate and further more may be used multipletimes in the same lobe to achieve the desired effect.

FIG. 4H″ shows a coronal section through the prostate gland showing thefinal deployed configuration of an embodiment of bone anchoring devicesfor treating prostate gland disorders by compressing a region of theprostate gland. In the method of deploying this device, introducersheath 340 and trocar 360 are advanced till the distal tip of trocar 360penetrates a bone in the abdomen (e.g. the pelvic bone, etc.) and thedistal end of introducer sheath 340 is located outside the bone.Thereafter, trocar 360 is withdrawn from working device lumen 302leaving introducer sheath 340 in place. Thereafter, anchor deliverydevice 370 is introduced through the lumen of introducer sheath 340until the distal end of body 372 touches the bone through the distal tipof introducer sheath 340. Thereafter, distal anchor 374 is implanted inthe bone. Distal anchor 374 may comprise a variety of designs including,but not limited to designs of distal tips of Kirschner wires. Examplesof such Kirschner wire distal tips are spiral drill tips, lancer tips,threaded trocar tips, lengthwise knurled tips, 3-sided trocar tips,4-sided trocar tips, Thereafter, anchor deliver device 370 is pulled inthe proximal direction along with introducer sheath 340. This stepcreates tension in the tension element 378. In another methodembodiment, anchor deliver device 370 is pulled in the proximaldirection along with introducer sheath 340 till the distal end of anchordelivery device 370 is located in the urethral wall or the urethrallumen. The remaining method steps are similar to steps 4F through 4H.

One or more anchors disclosed in this patent application may beimplanted in anatomical locations that include, but are not limited to:

-   -   a location within prostatic lobe;    -   a location within peripheral zone of prostate;    -   a location within prostatic capsule;    -   a location between prostatic capsule and pubic fascia;    -   a location within the pubic fascia;    -   a location within the levator ani muscle    -   a location within the obturator internus muscle;    -   a location within the pelvic bone;    -   a location within the periostium of pelvic bone;    -   a location within the pubic bone;    -   a location within the periostium of pubic bone;    -   a location within the symphysis pubica;    -   a location within the urinary bladder wall;    -   a location within the ischiorectal fossa;    -   a location within the urogenital diaphragm; and    -   a location within the abdominal fascia.

FIGS. 4I and 4J show a crossection of the urethra through the prostategland PG showing the appearance of the urethral lumen before and afterperforming the method shown in FIGS. 4A through 4H. FIG. 4I shows acrossection of the urethra through the prostate gland showing theappearance of the urethral lumen in a patient with BPH. FIG. 4J shows acrossection of the urethra through the prostate gland PG showing theappearance of the urethral lumen after performing the procedure shown inFIGS. 4A through 4H. The urethral lumen shown in FIG. 4I is larger thanthe urethral lumen in FIG. 4J.

FIGS. 5A through 5F show perspective views of some designs of thetension elements that can be used in the embodiments disclosed elsewherein this patent application. FIG. 5A shows a perspective view of atension element 500 comprising a single strand of an untwisted material.Examples of materials that can be used to manufacture tension element500 include but are not limited to synthetic fibers e.g. various gradesof Nylon, polyethylene, polypropylene, polyester, Aramid etc.; metalse.g. various grades of stainless steel, titanium, nickel-titaniumalloys, cobalt-chromium alloys, tantalum etc.; natural fibers e.g.cotton, silk etc.; rubber materials e.g. various grades of siliconerubber etc. FIG. 5B shows a perspective view of a tension element 502comprising one or more serrations 504 or notches. Serrations 504 may bealigned in a particular direction to allow relatively easy movement ofan outer body along tension element 502 in one direction and offersignificant resistance to movement of the outer body along the tensionelement in the other direction. FIG. 5C shows a perspective view of atension element 506 comprising multiple filaments 507 of a materialtwisted together. Examples of materials that can be used include tomanufacture multiple filaments 507 include but are not limited tosynthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber etc. multiple filaments507 may be coated with a coating 508 including, but not limited to alubricious coating, antibiotic coating, etc. It is also possible for thetension element to comprise a composite braided structure in aplastic/metal or plastic/plastic configuration to reduce profile andincrease strength. Such materials could have preset levels of elasticityand non-elasticity. FIG. 5D shows a perspective view of a tensionelement 509 comprising a flexible, elastic, spiral or spring element.Other of the contemplated devices lack a spring (See for example FIG.5G, described further below). Examples of materials that can be usedinclude to manufacture tension element 509 include but are not limitedto metals e.g. various grades of stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc. FIG. 5Eshows a perspective view of a tension element 510 comprising a screwthreading 511 on the outer surface of tension element 510. Screwthreading 511 enables tension element 510 to be screwed through an outerelement to advance or withdraw tension element through the outerelement. FIG. 5F shows a perspective view of a tension element 512comprising a hollow shaft 514 comprising one or more collapsible regions516. A collapsible region 516 comprises one or more windows 518. Windows518 are cut in hollow shaft 514 in such a way that several thin,collapsible struts 520 are created between adjacent windows 518. Whentension element 512 is compresses along its length, collapsible struts520 are deformed in the radially outward direction to create one or moreanchoring regions.

FIG. 5G shows a perspective view of an anchoring device 522 comprising atension element and two anchors. Distal end of a tension element 524 isattached to a distal anchor 526. Proximal end of tension element 524 isattached to a proximal anchor 528.

FIG. 5H shows a perspective view of a tensioning element devicecomprising a detachable region. Anchoring device 530 comprises a firstanchor 532 and a second anchor 534. First anchor 532 and second anchor534 may comprise a variety of anchor designs disclosed elsewhere in thispatent application. In one embodiment, one or both of first anchor 532and second anchor 534 comprise a substantially flat plate. Thesubstantially flat plate may be made from various materials including,but not limited to metals e.g. various grades of stainless steel,titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;polymers e.g. polypropylene, Teflon etc.; synthetic fibers e.g. variousgrades of Nylon, polyethylene, polypropylene, polyester, Aramid etc.;natural fibers e.g. cotton, silk etc.; rubber materials e.g. variousgrades of silicone rubber etc. First anchor 532 and second anchor 534are connected to a tensioning element. The tensioning element comprisestwo flexible members: a first tensioning member 536 and a secondtensioning member 538. The distal end of first tensioning member 536 isconnected to first anchor 532 and the proximal end of second tensioningmember 538 is connected to second anchor 534. Proximal end of firsttensioning member 536 and distal end of second tensioning member 538 areconnected to a releasable member 540. Releasable member 540 can bereleasably connected to a deploying device. In one embodiment of amethod using anchoring device 530, first anchor 532 is deployed out ofan anatomical tissue (e.g. the prostate gland) into a first anatomicalcavity (e.g. the pelvic cavity). Thereafter, second anchor 534 isdeployed into a second anatomical cavity (e.g. the urethral lumen).Thereafter, releasable member 540 is released from the deploying deviceto deliver anchoring device 530 in a target region.

FIG. 5I shows a perspective view of a tensioning element comprisingtelescoping tubes. Tensioning element 544 may comprise two or moretelescoping tubes. In this example, tensioning element 544 comprisesthree telescoping tubes: a first telescoping tube 546, a secondtelescoping tube 548 and a third telescoping tube 550. Secondtelescoping tube 548 slidably fits into a lumen of first telescopingtube 546. Similarly third telescoping tube 550 slidably fits into alumen of second telescoping tube 548. The telescoping tubes have alocking mechanism to prevent a telescoping tube from completelydisengaging from another telescoping tube. The telescoping tubes may bemade from a variety of biocompatible materials including, but notlimited to plastics, metals etc.

All the components of the systems disclosed herein (including but notlimited to the tensioning elements, inner and outer anchor members) maybe coated or embedded with therapeutic or diagnostic substances (e.g.,drugs or therapeutic agents) or such therapeutic or diagnosticsubstances may be introduced into or near the prostate or adjacenttissue through a catheter, cannula needles, etc. Examples of therapeuticand diagnostic substances that may be introduced or eluted include butare not limited to: hemostatic agents; antimicrobial agents(antibacterials, antibiotics, antifungals, antiprotozoals; antivirals;antimicrobial metals (e.g., silver, gold, etc.); hemostatic and/orvasoconstricting agents (e.g., pseudoephedrine, xylometazoline,oxymetazoline, phenylephrine, epinephrine, cocaine, etc.); localanesthetic agents (lidocaine, cocaine, bupivacaine); hormones;anti-inflammatory agents (steroidal and non-steroidal); hormonallyactive agents; agents to enhance potency; substances to dissolve,degrade, cut, break, weaken, soften, modify or remodel connective tissueor other tissues; (e.g., enzymes or other agents such as collagenase(CGN), trypsin, trypsin/EDTA, hyaluronidase, and tosyllysylchloromethane(TLCM)); chemotherapeutic or antineoplastic agents; substances thatprevent adhesion formation (e.g., hyaluronic acid gel); substances thatpromote desired tissue ingrowth into an anchoring device or otherimplanted device; substances that promote or facilitateepithelialization of the urethra or other areas; substances that createa coagulative lesion which is subsequently resorbed causing the tissueto shrink; substances that cause the prostate to decrease in size;phytochemicals that cause the prostate to decrease in size;alpha-1a-adrenergic receptor blocking agents; 5-alpha-reductaseinhibitors; smooth muscle relaxants; agents that inhibit the conversionof testosterone to dihydrotestosterone, etc. Specific examples ofantitumor agents (e.g., cancer chemotherapeutic agents, biologicalresponse modifiers, vascularization inhibitors, hormone receptorblockers, cryotherapeutic agents or other agents that destroy or inhibitneoplasia or tumorigenesis) that may be delivered in accordance with thepresent invention include but are not limited to; alkylating agents orother agents which directly kill cancer cells by attacking their DNA(e.g., cyclophosphamide, isophosphamide), nitrosoureas or other agentswhich kill cancer cells by inhibiting changes necessary for cellular DNArepair (e.g., carmustine (BCNU) and lomustine (CCNU)), antimetabolitesand other agents that block cancer cell growth by interfering withcertain cell functions, usually DNA synthesis (e.g., 6 mercaptopurineand 5-fluorouracil (5FU), antitumor antibiotics and other compounds thatact by binding or intercalating DNA and preventing RNA synthesis (e.g.,doxorubicin, daunorubicin, epirubicin, idarubicin, mitomycin-C andbleomycin) plant (vinca) alkaloids and other anti-tumor agents derivedfrom plants (e.g., vincristine and vinblastine), steroid hormones,hormone inhibitors, hormone receptor antagonists and other agents whichaffect the growth of hormone-responsive cancers (e.g., tamoxifen,herceptin, aromatase inhibitors such as aminoglutethamide andformestane, trriazole inhibitors such as letrozole and anastrazole,steroidal inhibitors such as exemestane), antiangiogenic proteins, smallmolecules, gene therapies and/or other agents that inhibit angiogenesisor vascularization of tumors (e.g., meth-1, meth-2, thalidomide),bevacizumab (Avastin), squalamine, endostatin, angiostatin, Angiozyme,AE-941 (Neovastat), CC-5013 (Revimid), medi-522 (Vitaxin),2-methoxyestradiol (2ME2, Panzem), carboxyamidotriazole (CAI),combretastatin A4 prodrug (CA4P), SU6668, SU11248, BMS-275291, COL-3,EMD 121974, IMC-1C11, IM862, TNP-470, celecoxib (Celebrex), rofecoxib(Vioxx), interferon alpha, interleukin-12 (IL-12) or any of thecompounds identified in Science Vol. 289, Pages 1197-1201 (Aug. 17,2000) which is expressly incorporated herein by reference, biologicalresponse modifiers (e.g., interferon, bacillus calmette-guerin (BCG),monoclonal antibodies, interluken 2, granulocyte colony stimulatingfactor (GCSF), etc.), PGDF receptor antagonists, herceptin,asparaginase, busulphan, carboplatin, cisplatin, carmustine,chlorambucil, cytarabine, dacarbazine, etoposide, flucarbazine,fluorouracil, gemcitabine, hydroxyurea, ifosphamide, irinotecan,lomustine, melphalan, mercaptopurine, methotrexate, thioguanine,thiotepa, tomudex, topotecan, treosulfan, vinblastine, vincristine,mitoazitrone, oxaliplatin, procarbazine, streptocin, taxol, taxotere,analogs/congeners and derivatives of such compounds as well as otherantitumor agents not listed here.

Additionally or alternatively, in some applications such as those whereit is desired to grow new cells or to modify existing cells, thesubstances delivered in this invention may include cells (mucosal cells,fibroblasts, stem cells or genetically engineered cells) as well asgenes and gene delivery vehicles like plasmids, adenoviral vectors ornaked DNA, mRNA, etc. injected with genes that code foranti-inflammatory substances, etc., and, as mentioned above, macrophagesor giant cells that modify or soften tissue when so desired, cells thatparticipate in or effect the growth of tissue.

FIGS. 6A through 11A show various examples of anchor designs and/oranchoring device designs. FIGS. 6A and 6B show examples of a crumplinganchor 600. In FIG. 6A, crumpling anchor 600 comprises a substantiallyflattened body 602. Body 602 can be made of a variety of materialsincluding, but not limited to synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; metals e.g.various grades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; natural fibers e.g. cotton, silketc.; rubber materials e.g. various grades of silicone rubber etc.Further, in any of the implantable tissue compression devices, any orall of the anchors, the tensioning elements(s) and any other componentsmay be coated, impregnated, embedded or otherwise provided withsubstance(s) (e.g., drugs, biologics, cells, etc.) to reduce thelikelihood of infection, inflammation, treat the prostatic adenomadirectly or enhance the likelihood of endothelialization, deter adhesionformation, promote healing or otherwise improve the likelihood or degreeof success of the procedure. Such substance(s) may be released primarilyat the time of delivery or may be released over a sustained period.Examples of such substances are listed above and include but are notlimited to certain metals with bacteriostatic action (i.e. silver, gold,etc.), antibiotics, antifungals, hemostatic agents (i.e. collagen,hyaluronic acid, gelfoam, cyano-acrylate, etc.), anti-inflammatoryagents (steroidal and non-steroidal), hormonally active agents, stemcells, endothelial cells, genes, vectors containing genes, etc. Body 602may be non-woven or woven. Body 602 may have a variety of shapesincluding, but not limited to square, rectangular, triangular, otherregular polygonal, irregular polygonal, circular etc. Body 602 may havea substantially one dimensional, two dimensional or three dimensionalshape. The material chosen for this device may have hemostaticproperties to reduce bleeding from the implantation tract or site.Distal end of body 602 is connected to the distal end of tension element604. Body 602 further comprises one or more attachment means 606.Attachment means are used to create a channel in the body 602 throughwhich tension element 604 passes. Crumpling anchor 600 is introducedthrough a region of tissue (e.g. through prostate gland tissue) into acavity or lumen e.g. pelvic cavity, urethral lumen etc. In FIG. 6B,tension element 604 is pulled in the proximal direction. The causescrumpling (e.g., collapsing) of the crumpling anchor 600 between thetissue and the distal end of tension element 604. This process preventstension element 604 in the tissue and prevents further movement oftension element 604 in the proximal direction.

FIGS. 7A and 7B show an example of a deployable anchor 700 in anundeployed configuration and a deployed configuration, respectively.This deployable anchor 700 comprises one or more anchoring arms 702.Anchoring arms 702 may be made from a variety of elastic, super-elasticor shape memory materials etc. Typical examples of such materialsinclude but are not limited to metals e.g. stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc. Anchoringarms 702 are connected to a central hub 704. Central hub in turn isconnected to the distal end of a tension element 706. In FIG. 7A,anchoring arms 702 are folded inside a hollow deploying sheath 708. Thisreduces the undeployed diameter of anchoring arms 702 and also preventsunwanted anchoring of anchoring arms 702. In FIG. 7B, deploying sheath708 is pulled in the proximal direction. This releases anchoring arms702 from the distal end of deploying sheath 702. This causes anchoringarms 702 to open in the radially outward direction. Anchor 700 can thenanchor to tissue and resist movement of tension element 706 in theproximal direction.

FIGS. 8A and 8B show sectional views of an undeployed configuration anda deployed configuration respectively of a “T” shaped deployable anchor.Anchor 8110 comprises an elongate region 802. Elongate region 802 may bemade from a variety of elastic, super-elastic or shape memory materialsetc. Typical examples of such materials include but are not limited tometals e.g. stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc; polymers e.g. polypropylene,Teflon etc. Middle section of elongate region 802 is connected to thedistal end of a tension element 804 to form a “T” shaped anchor. In oneembodiment, middle section of elongate region 802 is connected to thedistal end of a tension element 804 by a hinge. In FIG. 8A, elongateregion 802 is folded inside a hollow deploying sheath 806. This reducesthe undeployed diameter of the distal region of anchor 8110 and alsoprevents unwanted anchoring of elongate region 802 to tissue. In FIG.8B, deploying sheath 806 is pulled in the proximal direction. Thisreleases elongate region 802 from the distal end of deploying sheath806. This in turn causes elongate region 802 to twist and orient itselfperpendicular to the distal end of a tension element 804. Anchor 800 canthen anchor to tissue and resist movement of tension element 804 in theproximal direction.

Anchoring arms 702 in FIGS. 7A and 7B can have a variety ofconfigurations including, but not limited to configurations shown inFIGS. 9A through 9D. FIG. 9A shows a distal end view of an embodiment ofan anchor comprising two triangular arms. Anchor 900 comprises twoanchor arms 902. Anchor arms 902 can be made of a variety of materialsincluding, but not limited to metals e.g. stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc; polymerse.g. polypropylene, Teflon etc. Anchor arms 902 are connected to atension element 904. In one embodiment, anchor arms 902 are connected toa central hub, which in turn is connected to tension element 904. Thearms in each of these devices may be folded or contained prior todeployment through the use of a sheath or grasping or mounting device.FIG. 9B shows a distal end view of an embodiment of an anchor comprisingfour rectangular arms. Anchor 906 comprises four anchor arms 908. Anchorarms 908 can be made of a variety of materials including, but notlimited to metals e.g. stainless steel, titanium, nickel-titaniumalloys, cobalt-chromium alloys, tantalum etc; polymers e.g.polypropylene, Teflon etc. Anchor arms 908 are connected to a tensionelement 910. In one embodiment, anchor arms 908 are connected to acentral hub, which in turn is connected to tension element 910. FIG. 9Cshows a distal end view of an embodiment of an anchor comprising a meshor a woven material. Anchor 912 comprises four anchor arms 914. Anchorarms 914 can be made of a variety of materials including, but notlimited to metals e.g. stainless steel, titanium, nickel-titaniumalloys, cobalt-chromium alloys, tantalum etc; polymers e.g.polypropylene, Teflon etc. Anchor arms 914 are connected to a tensionelement 916. In one embodiment, anchor arms 914 are connected to acentral hub, which in turn is connected to tension element 916. A layerof porous material 918 is located between anchor arms 914. Porousmaterial 918 comprises a plurality of pores that allow for tissueingrowth. Porous material 918 may also help to distribute the pressureon anchor arms 914 over a wider area. Porous material 918 can be made ofvariety of materials including, but not limited to synthetic fibers e.g.various grades of Nylon, polyethylene, polypropylene, polyester, Aramidetc.; metals e.g. various grades of stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.; naturalfibers e.g. cotton, silk etc.; rubber materials e.g. various grades ofsilicone rubber etc. Porous material 918 may be non-woven or woven. Anyof the arms or struts in one or more anchoring devices may comprise bentor curved regions. For example, FIG. 9D shows a distal end view of anembodiment of an anchor comprising four curved arms. Anchor 920comprises four curved anchor arms 922. Curved anchor arms 922 can bemade of a variety of materials including, but not limited to metals e.g.stainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc; polymers e.g. polypropylene, Teflon etc. Curvedanchor arms 922 are connected to a tension element 924. In oneembodiment, curved anchor arms 922 are connected to a central hub whichin turn is connected to tension element 924.

FIG. 10A shows a distal end view of an anchor comprising a spiralelement having a three dimensional shape. Anchor 1000 comprises a threedimensional spiral element 1002. Diameter of spiral element 1002 may besubstantially constant or may substantially vary along the length ofspiral element 1002. Spiral element 1002 may be made of an elastic,super-elastic or shape memory materials. Spiral element 1002 may be madeof a variety of materials including, but not limited to metals e.g.various grades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,Teflon etc.; synthetic fibers e.g. various grades of Nylon,polyethylene, polypropylene, polyester, Aramid etc.; natural fibers e.g.cotton, silk etc.; rubber materials e.g. various grades of siliconerubber etc. Spiral element 1002 is connected to a central hub 1004,which in turn is connected to a tension element. In one embodiment,spiral element 1002 is directly connected to a tension element withoutusing central hub 1004. FIG. 10A′ shows a side view of the anchor inFIG. 10A. FIG. 10A′ shows anchor 1000 comprising spiral element 1002connected to central hub 1004 which in turn is connected to a tensionelement 1006. FIG. 10B shows a distal end view of an anchor comprising aspiral element having a two dimensional shape. Anchor 1000 comprises atwo dimensional spiral element 1010. Spiral element 1010 may be made ofan elastic, super-elastic or shape memory materials. Spiral element 1010may be made of a variety of materials including, but not limited tometals e.g. various grades of stainless steel, titanium, nickel-titaniumalloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.polypropylene, Teflon etc.; synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; naturalfibers e.g. cotton, silk etc.; rubber materials e.g. various grades ofsilicone rubber etc. Spiral element 1010 is connected to a central hub1012 which in turn is connected to a tension element. In one embodiment,spiral element 1010 is directly connected to a tension element withoutusing central hub 1012. FIG. 10B′ shows a side view of the anchor inFIG. 10B. FIG. 10B′ shows anchor 1008 comprising spiral element 1010connected to central hub 1012 which in turn is connected to a tensionelement 1014. FIG. 10C shows a distal end view of an anchor comprisingone or more circular elements. In FIG. 10C, anchor 1016 comprises aninner circular element 1018 and an outer circular element 1020. A seriesof radial arms or struts 1022 connect inner circular element 1018 toouter circular element 1020 and to a central hub 1024. Central hub 1024may have a lumen 1026. Anchor 1016 may be substantially two dimensionalor three dimensional. FIG. 10C′ shows a perspective view of the anchorin FIG. 10C. FIG. 10C′ shows an anchor 1016 comprising an inner circularelement 1018, an outer circular element 1020 and series of radial armsor struts 1022 connecting inner circular element 1018 to outer circularelement 1020 and to a central hub 1024. Central hub 1024 is connected toa tension element.

FIG. 10D shows a perspective view of an embodiment of an anchoringdevice comprising an outer ring. Anchor 1040 comprises a central hub1042 and an outer ring 1044. In one embodiment, central hub 1042 acts asa plug to plug an opening in the anatomy to reduce or prevent bleedingor leakage of fluids. Central hub 1042 is connected to outer ring 1044by one or more bars or struts 1046. In one embodiment, central hub 1042is connected to an inner ring 1048 which in turn is connected to outerring 1044 by one or more bars or struts 1046. Central hub 1042 furthercomprises a locking element 1050. Locking element 1050 comprises a lumen1052 through which a tension element can slide. After positioning anchor1040 in a desired position with respect to the tension element, lockingelement 1050 is used to securely attach anchor 1040 on the tensionelement. Locking element 1050 may comprise a design disclosed includingvarious locking designs disclosed elsewhere in this patent application.Anchor 1040 may be made from a variety of materials including, but notlimited to synthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber etc.

FIG. 10E shows a partial perspective view of an anchoring devicecomprising a hemostatic element. Anchor 1060 comprises a central hub1062. In one embodiment, central hub 1062 acts as a plug to plug anopening in the anatomy to reduce or prevent bleeding or leakage offluids. Central hub 1062 comprises a cinching mechanism to allow centralhub 1062 to cinch on to a tension element 1064 passing through centralhub 1062. The free end 1066 of tension element 1064 is severed tominimize the presence of tension element 1064 in the anatomy. Anchor1060 further comprises an outer ring 1068. Central hub 1062 is connectedto outer ring 1068 by one or more struts 1070. Anchor 1060 furthercomprises a mesh or porous element 1072 between outer ring 1068 andstruts 1070. The mesh or porous element 1072 may be concave shaped asshown in FIG. 10E. Mesh or porous element 1072 allows for tissueingrowth over a period of time thus providing additional securing ofanchor 1060 to tissue.

FIG. 11A shows a perspective view of a device having a set of anchorscomprising a curved sheet. Anchoring device 1100 may comprise one ormore anchors comprising a curved sheet. In this example, anchoringdevice 1100 comprises a first anchor 1102 and a second anchor 1104.First anchor 1102 and second anchor 1104 may comprise elastic, superelastic or shape memory materials. First anchor 1102 and second anchor1104 may be made from various materials including, but not limited tometals e.g. various grades of stainless steel, titanium, nickel-titaniumalloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.polypropylene, Teflon etc.; synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; naturalfibers e.g. cotton, silk etc.; rubber materials e.g. various grades ofsilicone rubber etc. The concave surface of first anchor 1102 isconnected to a first end of a tension element 1106. Second end oftension element 1106 is connected to the convex surface of second anchor1104. In one embodiment of a method to deploy anchoring device 1106,first anchor 1102 is deployed out of an anatomical tissue (e.g. theprostate gland) into a first anatomical cavity (e.g. the pelvic cavity).Thereafter, second anchor 1104 is deployed into a second anatomicalcavity (e.g. the urethral lumen). This method embodiment has theadvantage of using the natural curvature of first anchor 1102 and secondanchor 1104 to distribute pressure on first anchor 1102 and secondanchor 1104 over a large area.

FIGS. 12A through 17I show further examples of anchor designs and/oranchoring device designs. FIG. 12A shows a perspective view of an anchorcomprising an arrowhead. Anchor 1200 comprises an arrowhead 1202.Arrowhead 1202 may be made from various materials including, but notlimited to metals e.g. various grades of stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.; polymerse.g. polypropylene, Teflon etc.; rubber materials e.g. various grades ofsilicone rubber etc. Arrowhead 1202 may comprise a sharp distal tip.Arrowhead 1202 may have a three dimensional or a substantially twodimensional design. Proximal region of arrowhead 1202 is wider that thedistal region of arrowhead 1202 to resist motion of arrowhead 1202 alongthe proximal direction after it is deployed in a tissue. Proximal regionof arrowhead 1202 is connected to a tension element 1204. FIG. 12B showsa crossectional view of an anchor comprising a cup-shaped element thatencloses a cavity. Anchor 1208 comprises a cup-shaped element 1210.Proximal, concave surface of cup-shaped element 1210 encloses a cavity.Cup-shaped element 1210 may be made from various materials including,but not limited to metals e.g. various grades of stainless steel,titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;polymers e.g. polypropylene, Teflon etc.; rubber materials e.g. variousgrades of silicone rubber etc. Proximal region of cup-shaped element1210 is connected to a tension element 1212. FIG. 12C shows aperspective view of an anchor comprising a screw. Anchor 1216 comprisesa screw 1218. Screw 1218 may be made from various materials including,but not limited to metals e.g. various grades of stainless steel,titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;polymers e.g. polypropylene, Teflon etc. Screw 1218 may comprise a sharpdistal tip. Proximal region of screw 1218 may be wider that the distalregion of screw 1218 to resist motion of screw 1218 along the proximaldirection after it is deployed in a tissue. Screw 1218 comprises athread rolled thread including, but not limited to wood screw stylethread, double lead thread, tapping style thread, tapered wood threadetc. Proximal region of arrowhead 1202 is connected to a tension element1204.

FIGS. 13A and 13B show perspective views of an uncollapsed state and acollapsed state respectively of an anchor comprising a collapsibleregion. In FIG. 13A, anchor element 1300 is in an uncollapsed state.Anchor element 1300 comprises a hollow shaft 1302 comprising one or morecollapsible regions. A collapsible region comprises one or more windows1304. Windows 1304 are cut in hollow shaft 1302 in such a way thatseveral thin, collapsible struts 1306 are created between adjacentwindows 1304. In FIG. 13B, anchor element 1300 is in a collapsed state.When anchor element 1300 is compressed along its length, collapsiblestruts 1306 are deformed in the radially outward direction to create oneor more anchoring regions.

FIGS. 13C and 13D show perspective views of an undeployed state and adeployed state respectively of an anchor comprising radially spreadingarms. In FIG. 13C, anchor 1312 comprises a hollow tube 1314. Hollow tube1314 is made from suitable elastic, super-elastic or shape memorymaterials such as metals including, but not limited to titanium,stainless steel, Nitinol etc.; suitable elastic polymers etc. U-shapedslots 1316 are cut in hollow tube 1314 in such a way that arms 1318 arecreated within U-shaped slots 1316. In this embodiment, U-shaped slotsare substantially parallel to the axis of hollow tube 1314. In absenceof an external force, arms 1318 tend to spread in a radially outwarddirection. Anchor 1312 is kept in an undeployed state by enclosinganchor 1312 in a sheath. Anchor 1312 is deployed by removing the sheathto allow arms 1318 to spread in a radially outward direction as shown inFIG. 13D.

Hollow tube 1314 may comprise one or more cinching elements. Cinchingelements may be located on the proximal region, distal region or amiddle region of hollow tube 1314. The cinching element or elements maycomprise cinching mechanisms including, but not limited to cinchingmechanisms disclosed in FIGS. 26A through 29P.

FIG. 13E shows perspective views of an alternate embodiment of anundeployed state of an anchor comprising radially spreading arms. InFIG. 13C, anchor 1320 comprises a hollow tube 1322. Hollow tube 1322 ismade from suitable elastic, super-elastic or shape memory materials suchas metals including, but not limited to titanium, stainless steel,Nitinol etc.; suitable elastic polymers etc. U-shaped slots 1324 are cutin hollow tube 1322 in such a way that arms 1326 are created withinU-shaped slots 1324. In this embodiment, U-shaped slots are at an angleto the axis of hollow tube 1322 as shown in FIG. 13E.

FIGS. 14A and 14B show perspective views of anchoring devices comprisingan adhesive delivering element. FIG. 14A shows a perspective view of ananchoring device 1400 comprising a hollow shaft 1402 with a shaft lumen.Hollow shaft 1402 can be made of suitable biocompatible materialsincluding, but not limited to Pebax, Polyimide, Braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainlesssteel and fluoropolymers like PTFE, PFA, FEP and EPTFE etc. Distal endof shaft lumen ends in a delivery opening 1404. When an adhesive isinjected through the shaft lumen, it emerges out of anchoring device1400 through delivery opening 1404. Hollow shaft 1402 may also comprisean attachment element 1406 such as a porous woven or non-woven circularsleeve securely attached to hollow shaft 1402. The circular sleeve maybe made of a variety of materials including, but not limited to metalse.g. various grades of stainless steel, titanium, nickel-titaniumalloys, cobalt-chromium alloys, tantalum etc.; polymers e.g.polypropylene, Teflon etc.; synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; naturalfibers e.g. cotton, silk etc.; rubber materials e.g. various grades ofsilicone rubber etc. The adhesive flowing out through delivery openingcomes into contact with attachment element 1406 and securely attachesattachment element 1406 to surrounding tissue. FIG. 14B shows aperspective view of an anchoring device 1408 comprising a hollow shaft1410 with a shaft lumen. Hollow shaft 1410 can be made of suitablebiocompatible materials including, but not limited to Pebax, Polyimide,Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metalslike stainless steel and fluoropolymers like PTFE, PFA, FEP and EPTFEetc. Distal end of shaft lumen ends in a delivery opening 1412. When anadhesive is injected through the shaft lumen, it emerges out ofanchoring device 1408 through delivery opening 1412. Hollow shaft 1410may also comprise an attachment element 1414 such as porous foamsecurely attached to hollow shaft 1410. The porous foam may be made of avariety of materials including, but not limited to polymers e.g.polypropylene, Teflon etc.; synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; rubbermaterials e.g. various grades of silicone rubber etc. The adhesiveflowing out through delivery opening comes into contact with attachmentelement 1414 and securely attaches attachment element 1414 tosurrounding tissue. Typical examples of adhesives that can be used withanchoring device 1400 and anchoring device 1408 include but are notlimited to cyanoacrylates, marine adhesive proteins, fibrin-basedsealants etc.

FIGS. 15A and 15B show two configurations of an anchoring devicecomprising a ratcheted tension element. Anchoring device 1500 comprisesa distal anchor. Distal anchor may comprise a design selected from thevariety of designs disclosed elsewhere in this document. In thisparticular example, distal anchor comprises a series of radial arms 1502connected to a central hub 1504. The proximal end of central hub isattached to a ratcheted tension element 1506. A proximal anchor islocated on ratcheted tension element 1506 proximal to the distal anchor.Proximal anchor may comprise a design selected from the variety designsdisclosed elsewhere in this document. In this particular example, distalanchor comprises a series of radial arms 1508 connected to a central hub1510. Central hub 8368 has a central lumen through which ratchetedtension element 1506 can slide. Ratcheted tension element 1506 hasratchets arranged such that proximal anchor can slide easily overratcheted tension element 1506 in the distal direction but cannot slideeasily in the proximal direction. In FIG. 15B, proximal anchor slidesover ratcheted tension element 1506 in the distal direction. This causesa compression of tissue between distal anchor and proximal anchor. Thecompression of tissue can be maintained since proximal anchor cannotslide easily in the proximal direction. In one embodiment of a methodusing anchoring device 1500, distal anchor is introduced via ananatomical lumen (e.g. the urethral lumen) and through a tissue (e.g.the prostate gland) into an anatomical cavity (e.g. the pelvic cavity).Thereafter, proximal anchor is advanced along ratcheted tension element1506 till it encounters a wall (e.g. the urethral wall) of theanatomical lumen. Anchoring device 1500 may be made from variousmaterials including, but not limited to metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; polymers e.g. polypropylene, Teflon etc.

FIG. 16 shows a perspective view of an anchor comprising a trocar lumen.Anchor 1600 comprises a hollow shaft 1602 comprising a lumen. A trocar1604 or a penetrating device can pass through hollow shaft 1602 suchthat the distal tip of trocar 1604 emerges out through the distal end ofhollow shaft 1602. Distal end of hollow shaft 1602 comprises a taperingregion 1606 with a smaller distal diameter and a larger proximaldiameter. Tapering region 1606 further comprises a series of sharpprojections 1608 located on the proximal end of tapering region 1606.Projections 1608 may be projecting in the proximal direction, radiallyoutward direction etc. Projections 1608 prevent the movement of anchor1600 in the proximal direction after it has penetrated through a tissue.Anchor 1600 may also comprise a sleeve 1610 located proximal to taperingregion 1606. Sleeve 1610 is made of a porous material that has aplurality of pores that allow for tissue ingrowth thus anchoring sleeve1610 firmly in tissue. Sleeve 1610 may also help to distribute thepressure on tapering region 1606 over a wider area. Sleeve 1610 may benon-woven or woven. Sleeve 1610 can be made of variety of materialsincluding, but not limited to synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; metals e.g.various grades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; natural fibers e.g. cotton, silketc.; rubber materials e.g. various grades of silicone rubber etc.

FIG. 17A shows a perspective view in the undeployed state of an anchorcomprising a rigid or partially flexible T element and a crumplingelement. In FIG. 17A, anchoring device 1700 comprises a distal, Telement 1702. The T element 1702 may be made of a variety of materialsincluding, but not limited to metals e.g. various grades of stainlesssteel, titanium, nickel-titanium alloys, cobalt-chromium alloys,tantalum etc.; polymers e.g. polypropylene, Teflon etc.; rubbermaterials e.g. various grades of silicone rubber etc. Further it may bea composite material or have cut out sections to allow it to be flexiblein certain dimensions but rigid in other dimensions. In this example, Telement 1702 is in the form of a hollow cylinder. The proximal end of Telement 1702 is in contact with the distal end of a delivery rod 1704.Delivery rod 1704 is hollow and is used to deliver T element 8266 in atarget anatomical region. A trocar 1705 can pass through delivery rod1704 and through T element 1702 such that the distal tip of trocaremerges through the distal end of rigid element 1702. The T-elementcould also be contained within a lumen of the trocar or may be thetrocar itself. of the T element 1702 is connected to the distal end of aflexible tension element 1706. Various connection means are possiblesuch as the tension element being tied or crimped to the T element, orpassing through a loop in the T element, or being adhered by adhesive orweld, or by being made of a continuous material which becomes the Telement. Although the T element is shown as a T, any shape which islarger in at least one dimension compared to its other dimensions couldappropriately be released and cause to change it's orientation toproduce an anchoring effect. Examples of materials that can be used tomanufacture tension element 1706 include but are not limited tosynthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber etc. A substantiallyflattened body 1708 is located on the distal region of tension element1706. Tension element 1706 is threaded through body 1708 in such a waythat tension element 1706 can slide through body 1708. Body 1708 may benon-woven or woven. Body 1708 can be made of a variety of materialsincluding, but not limited to synthetic fibers e.g. various grades ofNylon, polyethylene, polypropylene, polyester, Aramid etc.; metals e.g.various grades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; natural fibers e.g. cotton, silketc.; rubber materials e.g. various grades of silicone rubber etc. Body1708 may have a variety of shapes including, but not limited to square,rectangular, triangular, other regular polygonal, irregular polygonal,circular etc. Body 1708 may have a substantially one dimensional, twodimensional or three dimensional shape. FIGS. 17B and 17C show varioussteps of a method to deploy the anchoring device shown in FIG. 17A. InFIG. 17B, anchoring device 1700 is introduced in an anatomical cavity(e.g. the pelvic cavity) through a tissue (e.g. the prostate gland).Thereafter, trocar 1705 is withdrawn by pulling trocar 1705 in theproximal direction. Thereafter, delivery rod 1704 is withdrawn bypulling delivery rod 1704 in the proximal direction. Thereafter, tensionelement 1706 is pulled in the proximal direction. Tension element 1706in turn pulls T element 1702 in the proximal direction. In FIG. 17C,rigid element 1702 is pulled against a wall of the tissue (e.g. theprostate gland) but is unable to penetrate the tissue because of itssize. This causes body 1708 to crumple because of compression of body1708 between the wall of the tissue and rigid element 1702. Crumpledbody 1708 may be designed to cause tissue ingrowth or epithelializationin body 1708 as well as healing, hemostasis or a more even forcedistribution.

FIGS. 17D and 17E show perspective views of an undeployed and deployedconfiguration of an anchor comprising a rigid or partially flexible Telement with one or more openings or perforations. FIG. 17D shows aperspective view of an anchoring device 1720 comprising an anchor 1722.Anchor 1722 comprises a tubular body. The tubular body may comprise oneor more openings or perforations 1724 in the tubular body. Openings orperforations 1724 increase the flexibility of anchor 1722. This makes iteasier to navigate anchoring device 1720 through the anatomy beforereaching its target location. Further it enables anchoring device 1720to be passed through a tight bend in the anatomy or through a deliverydevice. Within tubular body of anchor 1722 is trocar tip 1727 that isfixedly attached to tensioning element 1728. In the embodiment shown inFIG. 17D, anchor 1722 comprises a lumen. A length of the distal end ofdeployment element 1726 passes through the proximal end of the lumen andabuts trocar tip 1727 that enables anchor 1722 to puncture tissue. In analternate embodiment trocar tip is fixedly attached to elongatedeployment element 1726 and is retracted fully into element 1729 uponanchor deployment. In an alternate embodiment, distal tip of deploymentdevice 1726 is not exposed through the distal end of anchor 1722. Distalend of anchor 1722 comprises a sharp tip to enable anchor 1722 topuncture tissue. Anchoring element 1720 further comprises a tensionelement 1728 attached to tubular body 1722. In this embodiment, distalend of tension element 1728 attached to the inner surface of the trocartip 1727. Proximal region of tension element 1728 passes throughdeployment element 1726. Anchor 1722 is deployed by pushing in a distaldirection one elongate deployment element 1726, that runs within lumenof anchor 1722 abutting trocar tip 1727 distally, in tandem with anotherelongate deployment element 1729 that abuts the proximal end of anchor1722. Anchoring device 1720 punctures tissue to transport anchor 1722through a first anatomical location (e.g. a prostate gland) to a secondanatomical location (e.g. the pelvic cavity, urethra etc.). Thereafter,deployment element 1726 is withdrawn by pulling deployment element 1726in the proximal direction. Thereafter, tension element 1728 is pulled inthe proximal direction. This causes anchor 1722 to anchor in tissue asshown in FIG. 17E. Proximal portion of tension element 1728 emerges outof anchor 1722 through a lengthwise groove in anchor 1722 to create a Tshaped anchor as shown in FIG. 17E. Tension on tensioning element 1728causes trocar tip 1727 to retract into lumen 1722. In the example shown,the first anatomical location is the prostate gland PG and the secondanatomical location is the pelvic cavity. Anchoring device 1720 can bemade from a variety of materials including, but not limited to metalssuch as synthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber etc. Tension element1728 may then be connected to any one of the other anchoring elementssuch as anchor 10D.

FIGS. 17F and 17G show perspective views of an undeployed and deployedconfiguration of an anchor comprising a stent. Anchor 1730 comprises aself-expanding stent 1732 and a tension element 1734. Distal end oftension element 1734 is attached to stent 1732. In one embodiment,distal end of tension element 1734 is attached on the mid section ofstent 1732. Stent 1732 may comprise various designs including, but notlimited to metallic tube designs, polymeric tube designs, spiraldesigns, chain-linked designs, rolled sheet designs, single wire designsetc. Stent 1732 may have an open celled or closed celled structure. Avariety of fabrication methods can be used for fabricating stent 1732including but not limited to laser cutting a metal or polymer element,welding metal elements etc. A variety of materials can be used forfabricating stent 1732 including but not limited to metals, polymers,foam type materials, super elastic materials etc. A variety of featurescan be added to stent 1732 including but not limited to radiopaquecoatings, drug elution mechanisms etc. Anchor 1730 is introduced througha sheath 1736 into a target anatomy. Thereafter, sheath 1736 iswithdrawn. This causes stent 1732 to revert to its natural shape asshown in FIG. 17G and act as an anchor.

FIGS. 17H and 17I show perspective views of an undeployed and deployedconfiguration of an anchor comprising a spring. Anchor 1740 comprises anelastic spring 1742 and a tension element 1744. Distal end of tensionelement 1744 is attached to spring 1742. In one embodiment, distal endof tension element 1744 is attached on the mid section of spring 1742. Avariety of materials can be used for fabricating spring 1742 includingbut not limited to metals, polymers, foam type materials, super elasticmaterials etc. A variety of features can be added to spring 1742including but not limited to radiopaque coatings, drug elutionmechanisms etc. Anchor 1740 is introduced through a sheath 1746 into atarget anatomy to reduce the profile of spring 1742. Thereafter, sheath1746 is withdrawn. This causes spring 1742 to revert to its naturalshape as shown in FIG. 17I and act as an anchor.

FIGS. 18A through 22E show various embodiments of mechanisms to deployone or more anchors. FIG. 18A shows a crossection of an anchor deployingmechanism comprising a screw system. FIG. 18A shows an anchor deployingmechanism comprising an anchor 1800 comprising an anchor body 1802 andanchoring elements 1804 attached to anchor body 1802. Anchor body 1802comprises an inner lumen. Inner lumen of anchor body 1802 comprisesscrew threading. Anchoring elements 1804 may have various designsincluding, but not limited to anchor designs disclosed elsewhere in thisdocument. Anchor body 1802 and anchoring elements 1804 may be made of avariety of materials including, but not limited to metals e.g. variousgrades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,Teflon etc.; rubber materials e.g. various grades of silicone rubberetc. The anchor deploying mechanism further comprises a deploying shaft1806. Distal region of deploying shaft 1806 comprises a screw threadingsuch that deploying shaft 1806 can be screwed into anchor body 1802.FIG. 18B shows the method of deploying an anchor comprising a screwmechanism. Deploying shaft 1806 is rotated to release the distal regionof deploying shaft 1806 from anchor body 1802 after positioning anchor1800 in a desired location. Such a mechanism can be used to deploy oneor more anchors. In one embodiment, more than one anchors are located ondeploying shaft 1806. The anchors can be sequentially deployed byrotating deploying shaft 1806. Deploying shaft 1806 may be made of avariety of materials including, but not limited to metals e.g. variousgrades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,Teflon etc. In one embodiment, the anchor deploying mechanism is locatedinside an outer sheath.

FIGS. 19A and 19B show a crossectional view of an anchor deployingsystem comprising an electrolytic detachment element. FIG. 19A shows acrossection of an anchor deploying mechanism comprising a deployableanchor 1900. Deployable anchor 1900 comprises an anchor body 1902 andanchoring elements 1904 attached to anchor body 1902. Anchoring elements1904 may have various designs including, but not limited to anchordesigns disclosed elsewhere in this document. Anchor body 8402 andanchoring elements 8404 may be made of a variety of materials including,but not limited to metals e.g. various grades of stainless steel,titanium, nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.;polymers e.g. polypropylene, Teflon etc.; rubber materials e.g. variousgrades of silicone rubber etc. Proximal region of deployable anchor 1900further comprises an electrolyzable element 1906. Electrolyzable element1906 is made of a length of metallic wire e.g. steel wire. Proximalregion of electrolyzable element 1906 is electrically connected to adeploying shaft 1908. Proximal region of deploying shaft 1908 is furtherconnected to a first electrode. The anchor deploying system furthercomprises a second electrode 1910 connected to a bodily region of thepatient to be treated. In FIG. 19B, the first electrode is connected toa positive terminal of a power supply and the second electrode isconnected to the negative terminal of the power supply to form anelectrical circuit. Electrical current flowing between electrolyzableelement 1906 and second electrode 1910 causes metallic ions fromelectrolyzable element 1906 to dissolve into surrounding anatomy. Thiscauses electrolyzable element 1906 to detach from deploying shaft 1908.

FIG. 20 shows a perspective view of an anchor deploying systemcomprising a looped ribbon. The anchor deploying system comprises adeployable anchor 2000. Deployable anchor 2000 comprises an anchor body2002 and anchoring elements 2004 attached to anchor body 2002. Anchoringelements 2004 may have various designs including, but not limited toanchor designs disclosed elsewhere in this document. Anchor body 2002and anchoring elements 2004 may be made of a variety of materialsincluding, but not limited to metals e.g. various grades of stainlesssteel, titanium, nickel-titanium alloys, cobalt-chromium alloys,tantalum etc.; polymers e.g. polypropylene, Teflon etc.; rubbermaterials e.g. various grades of silicone rubber etc. Proximal region ofdeployable anchor 2000 further comprises a looping lumen 2006. A loopedribbon 2008 is looped through looping lumen 2006. Looped ribbon 2008 maybe made of a variety of materials including, but not limited tosynthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber etc. looped ribbon 2008extends to a proximal region where it can be cut by a user. In a methodof deploying deployable anchor 2000, a single cut is made in loopedribbon 2008 at a proximal region. This turns looped ribbon 2008 into astraight ribbon. The straight ribbon can then be pulled in the proximaldirection to remove it from deployable anchor 2000. Looped ribbon 2008may also be in the form of a looped monofilament or multifilament wireor suture.

FIG. 21A shows a crossectional view of an anchor deploying systemcomprising a locked ball. The anchor deploying system comprises adeployable anchor 2100. Deployable anchor 2100 comprises an anchor body2102. Deployable anchor 2100 may have various designs including, but notlimited to anchor designs disclosed elsewhere in this document. Proximalend of anchor body 2102 is connected to a thin shaft 2104. Proximal endof thin shaft 2104 comprises a locking ball 2106. Anchor body 8428, thinshaft 2104 and locking ball 2106 may be made of a variety of materialsincluding, but not limited to metals e.g. various grades of stainlesssteel, titanium, nickel-titanium alloys, cobalt-chromium alloys,tantalum etc.; polymers e.g. polypropylene, Teflon etc.; rubbermaterials e.g. various grades of silicone rubber etc. The anchordeploying system further comprises an outer locking sheath 2108. Distalend of locking sheath 2108 comprises an opening 2110. Diameter ofopening 2110 is greater than the diameter of thin shaft 2104 but greaterthan diameter of locking ball 2106. Thus, locking ball 2106 is locked inlocking sheath 2108. The anchor deploying system further comprises adeploying shaft 2112 located within locking sheath 2108. Deploying shaft2112 can be pushed in the distal direction within locking sheath 2108 bya user. Locking sheath 2108 and deploying shaft 2112 may be made of avariety of materials including, but not limited to metals e.g. variousgrades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,Teflon etc. In one embodiment, distal region of locking sheath 2108comprises one or more longitudinal grooves or windows to allow distalregion of locking sheath 2108 to expand easily in the radial direction.FIGS. 21B and 21C show a method of deploying an anchor comprising alocked ball. In FIG. 21B, deploying shaft 2112 is pushed in the distaldirection by a user. This causes distal end of deploying shaft 2112 topush locking ball 2106 in the distal direction. This in turn causeslocking ball 2106 to exert a force on the distal end of locking sheath2108. This force causes opening 2110 to enlarge and release locking ball2106. In FIG. 21C, locking ball 2106 is released by locking sheath 2108thus releasing deployable anchor 2100.

FIGS. 22A through 22C show various views of an anchor deploying systemcomprising two interlocking cylinders. The anchor deploying systemcomprises a proximal interlocking cylinder and a distal interlockingcylinder. The distal interlocking cylinder is located on an anchor to bedeployed. FIG. 22A shows a perspective view of a proximal interlockingcylinder 2200 comprising a locking element 2202 located on the distalend of proximal interlocking cylinder 2200. In this example, lockingelement 2202 comprises a solid cylinder with a ninety degree bend.Proximal interlocking cylinder 2200 and locking element 2202 may be madeof a variety of materials including, but not limited to metals e.g.various grades of stainless steel, titanium, nickel-titanium alloys,cobalt-chromium alloys, tantalum etc.; polymers e.g. polypropylene,Teflon etc. FIG. 22B shows a crossectional view of the anchor deployingsystem comprising proximal interlocking cylinder 2200 interlocked with adistal interlocking cylinder 2204. Distal interlocking cylinder 2204comprises a groove 2206 which locks locking element 2202. Lockingelement 2202 can be unlocked from distal interlocking cylinder 2204 byturning proximal interlocking cylinder 2200. Distal interlockingcylinder 2204 may be made of a variety of materials including, but notlimited to metals e.g. various grades of stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc.; polymerse.g. polypropylene, Teflon etc.; rubber materials e.g. various grades ofsilicone rubber etc. FIG. 22C shows a crossectional view through planeA-A in FIG. 22B. FIG. 22C shows distal interlocking cylinder comprisinggroove 2206. Also shown is locking element 2202 located in groove 2206.Turning proximal interlocking cylinder 2200 turns locking element 2202.At a particular orientation, distal region of locking element 2202 canpass easily through groove 2206 unlocking proximal interlocking cylinder2200 from distal interlocking cylinder 2204.

FIGS. 22D and 22E show the steps of a method of unlocking the twointerlocking cylinders from the anchor deploying systems of FIGS. 22Athrough 22C. In FIG. 22D, locking element 2202 of proximal interlockingcylinder 2200 is locked in groove 2206 of distal interlocking cylinder2204. In FIG. 22E, proximal interlocking cylinder 2200 is turned in aclockwise or counterclockwise direction to unlock locking element 2202from groove 2206. Thereafter, proximal interlocking cylinder 2200 ispulled in the proximal direction to separate proximal interlockingcylinder 2200 from distal interlocking cylinder 2204.

FIG. 23A shows a perspective view of a distal end of an anchoring devicethat has an imaging modality. Anchoring device 2300 comprises anelongate shaft 2302 comprising a lumen. Elongate shaft 2302 can be madeof suitable biocompatible materials such as metals, polymers etc. Thelumen of shaft 2302 terminates in a window 2304 located on the distalregion of shaft 2302. Anchoring device further comprises an imagingmodality such as a cystoscope, an ultrasound imaging system etc. In thisexample, the imaging modality is a cystoscope 2306. Distal end ofcystoscope 2306 is located in window 2304 to allow visualization of theanatomy adjacent to window 2304. In one embodiment, cystoscope 2306 ispermanently fixed to anchoring device 2300. In another embodiment,cystoscope 2306 can be introduced through the proximal region ofanchoring device 2300. Anchoring device 2300 further comprises apuncturing device 2308. Puncturing device 2308 comprises a sharp distaltip and a lumen that holds an anchor. Anchoring device 2300 furthercomprises an anchor deployment device 2310. Distal end of anchordeployment device 2310 is detachably attached to the anchor.

FIGS. 23B through 23G show various steps of a method for compressing ananatomical region using the anchoring device of FIG. 23A. In FIG. 23B,Anchoring device 2300 is introduced in an anatomical region such thatdistal end of anchoring device 2300 is located adjacent to a targetanatomical region to be treated. In one method embodiment, anchoringdevice 2300 is introduced transurethrally into the prostatic urethra.Thereafter, puncturing device 2308 is advanced to puncture theanatomical region. In this example, puncturing device 2308 punctures theprostate gland PG such that distal end of puncturing device 2308 islocated in the pelvic cavity. Puncturing device comprises an anchorlocated in the lumen of puncturing device 2308. The anchor comprises adistal anchor 2312, a tension element 2314 connected at one end todistal anchor 2312 and a proximal anchor 2316 that can slide overtension element 2314. Puncturing device 2308 comprises a groove at thedistal end such that tension element exits puncturing device 2308through the groove. Puncturing device 2308 further comprises a pusher2318 that can push distal anchor 2312 out of puncturing device 2308.Proximal anchor 2316 is detachably attached to the distal region ofanchor deployment device 2310. Proximal anchor 2312, distal anchor 2316and tension element 2314 may comprise designs including, but not limitedto the designs disclosed elsewhere in this patent application. Theimaging modality may be used to verify the accurate placement andworking of anchoring device 2300. In FIG. 23C, pusher 2318 is pushed inthe distal direction to push distal anchor 2312 out of puncturing device2308. Distal anchor 2312 is thus deployed in the anatomy e.g. in thepelvic cavity surrounding the prostate gland PG. Thereafter, in step23D, Puncturing device 2308 is withdrawn by pulling it in the proximaldirection. In step 23E, tension element 2314 is pulled in the proximaldirection through anchor deployment device 2310. Thereafter, in step23F, tension element 2314 is pulled further in the proximal directionsuch that the anatomical region between proximal anchor 2316 and distalanchor 2312 is compressed. Thereafter, in step 23G, proximal anchor 2316is securely locked on to tension element 2314. Further in step 23G,proximal anchor 2316 is detached from anchor deployment device 2310. Thedetachment can be performed by a variety of mechanisms including, butnot limited to the anchor detachment mechanisms disclosed elsewhere inthis patent application. Further in step 23G, excess length of tensionelement 2314 is removed. This removal can be done using a variety ofmethods including, but not limited to the methods disclosed elsewhere inthis patent application such as cutting, delinking, melting, andbreaking. Thereafter, anchoring device 2300 is withdrawn from theanatomy. It should be understood that these deployment steps may berepeated in the same, opposing or neighboring tissues to essentiallytack up the encroaching tissue (i.e. prostatic tissue, tumor, relaxedtissue, expanded tissue or growth). It may be desired that over timeboth anchors become completely embedded within the tissue and covered toprevent encrustation, clotting or other tissue or body-fluidinteraction—this may be facilitated by the processes, therapeutic agentsand coatings described elsewhere in the application. Although theseanchors are shown on either side of the tissue, it may be possible todeploy either or both of them within the body of the tissue itself tohelp bury them and eliminate the possibility that they may interact withother parts of the body. It should further be noted that in the case ofapplication to the prostate, that this technique may be used on any ofthe lateral or middle lobes to compress or hold the prostate gland PGaway from the lumen of the urethra.

If removal of the intra or para luminal anchor is required, it may bepossible to resect that region completely, capturing the anchor embeddedwithin the tissue and removing it en-bloc, severing the tether in theprocess. In the case of prostate applications, such removal may beaccomplished with a standard resectoscope system. In other regions, andenergized RF or sharp curette or blade may be used to resect the anchorminimally invasively. Alternatively if engagement with the lockingmechanism is still achievable, it may be possible to simply unlock thetether, releasing the anchor. Lastly, if applying additional tension atsome point after the procedure is required, it may be possible to engageand grasp the tether as it exits the locking device in the anchor andapply additional tension.

FIGS. 24A through 24C′ show various steps of a method of compressing ananatomical region using a device with deploying arms deployed through atrocar. In FIG. 24A, an anchoring device 2400 is introduced in ananatomical region. Anchoring device 2400 comprising a distal anchor 2402is introduced in the anatomy. Distal anchor 2402 comprises a hollowshaft. Distal end of distal anchor 2402 comprises one or more outwardlycurling or spreading arms 2404. Curling or spreading arms 2404 are madeof an elastic, springy, super-elastic or shape memory material such thatthey tend to curl or spread in a radially outward direction in absenceof an external force. Anchoring device 2400 further comprises a proximalanchor comprising a variety of designs including, but not limited to thedesigns disclosed elsewhere in this patent application. In this example,proximal anchor is designed similar to anchor 1040 in FIG. 10D. Anchor1040 can slide along proximal region of distal anchor 2402. Anchor 1040can also be attached to distal anchor 2402 after a desired positioningbetween anchor 1040 and distal anchor 2402 is achieved. Anchoring device2400 is delivered through a trocar 2406. Trocar 2406 comprises a sharpdistal tip 2408 that can penetrate through tissue. The proximal regionof distal tip 2408 comprises one or more grooves or notches such thatdistal ends of curling or spreading arms 2404 can be temporarily heldtogether by distal tip 2408 to allow for easy introduction into a targetanatomy. Anchoring device 2400 is introduced into a target tissue to becompressed such that curling or spreading arms 2404 are distal to thetarget tissue and anchor 1040 is proximal to the target tissue. FIG.24A′ shows the distal end view of the anchoring device 2400. In FIG.24B, trocar 2406 is pushed in the distal direction relative to proximalanchor 2402. This releases the distal ends of curling or spreading arms2404 causing them to curl or spread outwards. FIG. 24A′ shows the distalend view of the anchoring device 2400 with released curling or spreadingarms 2404. In FIG. 24C, anchor 1040 is pushed in the distal directionover distal anchor 2402 to compress tissue between anchor 1040 anddistal anchor 2402. Thereafter, anchor 1040 is attached to the hollowshaft of distal anchor 2402. Thereafter trocar 2406 is withdrawn fromthe anatomy. In the above embodiment, the tethering function isperformed by the shaft of the distal anchor, and the force is created bythe curling arms. This tension may be pre-set into the arms through heatforming. It should be noted that any mechanism capable of expanding fromwithin a tubular shape and capable of applying retrograde forces on thetissue are within the scope of this invention such as expandableflanges, balloons, cages, molly-bolt-like structures, stent-likestructures and springs.

FIG. 24D shows a crossection through the deployed anchoring device 2400of FIG. 24A.

In one anchoring device embodiment, anchoring device 2400 comprises adistal anchor such as the distal anchor described in FIG. 17A instead ofdistal anchor 2412.

FIG. 25A shows a perspective view of a spring clip that can be used tospread the anatomy. Clip 2500 comprises two or more spreading arms 2502.Spreading arms 2502 may be curved or straight. Distal ends of spreadingarms 2502 may comprise a flattened region. The proximal ends or curvedarms 2502 are connected to each other by a heel region 2504. Heel region2504 may be made from the same material as curved arms 2502. In anundeployed configuration, spreading arms 2502 are held close to eachother. When clip 2500 is deployed, spreading arms 2502 tend to expandaway from each other thus spreading the anatomical region or regionsbetween spreading arms 2502. Clip 2500 can be made of suitable elastic,super-elastic or shape memory biocompatible materials including, but notlimited to synthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, etc.

FIGS. 25B through 25F show various steps of a method of spreading ananatomical region or regions using the spring clip of FIG. 25A. In FIG.25B, a delivery tool 2506 comprising a clip 2500 is introduced in theanatomy and positioned near the target anatomy to be spread. Deliverytool 2506 comprises an elongate hollow body 2508 comprising a lumen.Distal end of body 2508 may comprise a blunt, atraumatic end. Distalregion of body 2508 comprises a slot 2510 that is in fluid communicationwith the lumen of body 2508. Delivery tool may further comprise an outersheath 2512 and an imaging modality 2514. Imaging modality 2514 may bepermanently attached to delivery tool 2506 or may be introduced intodelivery tool 2506 by a user. In this example, imaging modality 2514 isa cystoscope. In FIG. 25C, clip 2500 is introduced into the anatomy bypushing clip 2500 out of slot 2510 such that the distal ends ofspreading arms 2502 emerge first. Slot 2510 is designed such thatspreading arms 2504 are biased towards each other as they emerge out ofslot 2510. In FIG. 25D, clip 2500 is further advanced such that distaltips of spreading arms 2502 penetrate into the tissue to be spread. InFIG. 25E, clip 2500 is advanced further such that the biasing forces onspreading arms 2502 are removed. Spreading arms 2502 tend to spread awayfrom each other thus spreading the tissue between them. Clip 2500 isdetachably attached to delivery tool 2506 by a detaching mechanism 2516including, but not limited to the several detaching mechanisms disclosedelsewhere in this patent application. In FIG. 25F, detaching mechanism2516 is used to detach clip 2500 from delivery tool 2506 or deploy clip2500 in the target anatomy. In this example, distal region of deliverytool 2506 is inserted transurethrally into the prostatic urethra. Clip2500 is then delivered into the anterior commissure to spread the twolateral lobes of the prostate gland PG apart. In one method embodiment,an opening in the commissure is made prior to the method of FIGS. 25Bthrough 25G. In another embodiment, the spreading force exerted byspreading arms 2502 cause cutting of the anterior commissure. Clip 2500may be placed completely sub-urethrally or a small amount of heel region2504 remains in the urethra.

The embodiments of anchoring devices wherein a sliding anchor is slidover a tension element may comprise one or more cinching elements. Thesecinching elements may be present on the sliding anchors, on the tensionelements etc. A cinching element may be a separate device that cinchesto a tension element. In doing so, it increases the effective diameterof that region of the tension element and prevents the tension elementfrom sliding through a sliding anchor. Cinching elements may allow onlyunidirectional motion of the sliding anchor over the tension element ormay prevent any substantial motion of the sliding anchor over thetension element. Typical examples of such cinching mechanisms include,but are not limited to mechanisms described in the FIG. 26 series. Forexample, FIGS. 26A and 26B show a crossectional view and a perspectiveview respectively of a mechanism of cinching a tension element or tetherto an anchor. In FIG. 26A, cinching mechanism 2600 comprises an outerbase 2602. Outer base 2602 comprises one or more grooves created by thepresence of two or more leaflets 2604. Leaflets 2604 are biased along afirst axial direction as shown in FIG. 26A. When a tension element 2606is located in the one or more grooves, cinching mechanism 2600 allowsmotion of tension element 2606 only along the first axial direction andprevents substantial movement of tension element 2606 in the oppositedirection.

FIGS. 26C and 26D show a partial section through a cinching mechanismcomprising a cam element. In FIG. 26C, cinching mechanism 2610 comprisesan outer body 2612 made of suitable biocompatible metals, polymers etc.Body 2162 comprises a cam 2614 located on a pivot 2616. Cam 2614 maycomprise a series of teeth to grip a tension element 2618 passingthrough body 2612. In one embodiment, body 2162 comprises an opening2620 located proximal to cam 2614. Proximal region of tension element2618 passes out of body 2612 through opening 2620. Cinching mechanism2610 allows movement of body 2162 over tension element 2618 in theproximal direction. In FIG. 26D, body 2162 is moved over tension element2618 in the distal direction. Motion of tension element 2618 over cam2614 causes cam 2614 to turn in the anti-clockwise direction. Thiscauses tension element 2618 to be pinched between cam 2614 and body2612. This in turn prevents further motion of body 2162 over tensionelement 2618.

FIG. 26E shows a sectional view of an embodiment of a cinching mechanismcomprising a locking ball. Cinching mechanism 2630 comprises an outerbody 2632 comprising a lumen. A tension element 2634 passes through thelumen of outer body 2632. The lumen of outer body gradually reduces inthe proximal direction as shown in FIG. 26E. A locking ball 2636 ispresent in the lumen. Motion of outer body 2632 over tension element2634 in the distal direction pushes locking ball 2636 in the proximalregion of outer body 2632. A proximal end region 2638 of a smalldiameter prevents locking ball 2636 from falling out of outer body 2632.The large lumen diameter in the proximal region of outer body 2632allows free motion of locking ball 2636. Thus, presence of locking ball2636 does not hinder the motion of outer body 2632 over tension element2634 in the proximal direction. When outer body 2632 is moved overtension element 2634 in the proximal direction, locking ball 2636 ispushed in the distal region of outer body 2632. The small lumen diameterin the proximal region of outer body 2632 constricts motion of lockingball 2636. This causes a region of tension element 2634 to be pinchedbetween anchoring ball 2636 and outer body 2632. This in turn preventsfurther motion of outer body 2632 over tension element 2634 in theproximal direction. This mechanism thus allows unidirectional motion ofouter body 2632 is over tension element.

FIG. 26F shows a side view of an embodiment of a cinching mechanismcomprising multiple locking flanges. In this embodiment, cinchingmechanism 2644 comprises a body 2646 comprising a lumen lined by a firstlocking flange 2648 and a second locking flange 2650. First lockingflange 2648 and second locking flange 2650 are biased in the proximaldirection as shown. A tension element 2652 passes through the lumen ofbody 2646. First locking flange 2648 and second locking flange 2650together allow the movement of body 2646 over tension element 2652 inthe distal direction, but prevent movement of body 2646 over tensionelement 2652 in the proximal direction. Similar cinching mechanisms maybe designed comprising more than two locking flanges. FIG. 26G shows anend view of body 2646 comprising a lumen lined by first locking flange2648 and second locking flange 2650. Body 2646 may be made of suitablebiocompatible metals, polymers etc.

FIG. 26H shows a side view of an embodiment of a cinching mechanismcomprising a single locking flange. In this embodiment, cinchingmechanism 2656 comprises a body 2658 comprising a lumen lined by alocking flange 2660. Locking flange 2660 is biased in the proximaldirection as shown. A tension element 2662 passes through the lumen ofbody 2658. Locking flange 2660 allows the movement of body 2658 overtension element 2662 in the distal direction, but prevents movement ofbody 2658 over tension element 2662 in the proximal direction. FIG. 26Ishows an end view of body 2658 comprising a lumen 2662 lined by lockingflange 2660. Body 2658 may be made of suitable biocompatible metals,polymers etc.

FIG. 26J shows an end view of a cinching mechanism comprising a crimpinglumen. Cinching mechanism 2670 comprises a body 2672 comprising acrimping lumen 2674. Crimping lumen 2674 is in the form of an arc with agradually reducing size as shown in FIG. 26J. A tension element 2676passes through crimping lumen 2674. In FIG. 26J, tension element 2676 islocked in a region of crimping lumen 2674 of a diameter smaller than thediameter of tension element 2676. Tension element 2676 can be unlockedfrom crimping lumen 2674 by rotating body 2672 in the anti-clockwisedirection. Similarly, rotating body 2672 in the clockwise directioncauses an unlocked tension element 2676 to be locked into crimping lumen2674.

In an alternate embodiment, cinching mechanism comprises a disk shapedbody comprising a central lumen. Central lumen is large enough to allowa tension element to slide easily through the central lumen. One or moreradially oriented slits emerge from the central lumen. The radiallyoriented slits have a diameter that is of the same size or is slightlysmaller than the diameter of the tension element. To lock cinchingmechanism to the tension element, the tension element is forced throughone of the radially oriented slits. The friction between the disk shapedbody and the tension element prevents or resists sliding of tensionelement through the disk shaped body. To unlock cinching mechanism fromthe tension element, the tension element is moved back to the centrallumen.

In another alternate embodiment, cinching mechanism comprises a diskshaped body comprising a small central lumen. The central region of thebody comprises three or more triangular flaps biased together out of theplane of the body. The ends of the triangular flaps together form thecentral lumen that is of the same size or is slightly smaller than thediameter of the tension element. Tension element can pass easily throughthe central lumen in the direction of the bias of the triangular flaps.But, tension element cannot pass or encounters substantial resistancewhen the tension element is pulled through the central lumen in theopposite direction.

FIGS. 26K and 26L show crossections of an embodiment of a cinchingmechanism comprising a crimping anchor in the undeployed and deployedconfigurations respectively. Cinching mechanism 2680 comprises acrimping anchor 2680 comprising a lumen. Crimping anchor 2680 can bemade of a variety of biocompatible materials including, but not limitedto metals e.g. various grades of stainless steel, titanium,nickel-titanium alloys, cobalt-chromium alloys, tantalum etc., polymers,etc. A tension element 2684 passes through the lumen of crimping anchor2680. The lumen of an undeployed crimping anchor 2680 is larger than thediameter of tension element 2684. In FIG. 26L, crimping anchor 2680 isdeployed by compressing the middle section of crimping anchor 2680 suchthat crimping anchor 2680 compresses tension element 2684. Frictionbetween crimping anchor 2680 and tension element 2684 prevents relativemotion between crimping anchor 2680 and tension element 2684. Crimpinganchor 2680 may be a component of a sliding anchor or may be astand-alone device used to prevent or restrict motion of a slidinganchor over a tension element.

FIG. 26M shows a perspective view of an embodiment of a cinchingmechanism comprising an element providing a tortuous path to a tensionelement. In this example, cinching mechanism 2686 comprises a spring2688. A tension element 2690 is passed through spring 2688 such that thepath of tension element 2690 through spring 2688 is tortuous. Whenspring 2688 is moved over tension element, motion of tension element2690 through the tortuous path generates high frictional forces thatprevent or reduce motion of spring 2688 over tension element 2690. Thefrictional forces are strong enough to resist motion of spring 2688 overtension element 2690 after deploying cinching mechanism 2686 in theanatomy. A user can move spring 2688 over tension element 2690 byapplying a force that overcomes the resistive frictional forces thatprevent movement of spring 2688 over tension element 2690. Similarly,other cinching mechanisms comprising a tortuous path can be used insteadof spring 2688. Examples of such mechanisms are solid elementscomprising tortuous lumens, elements comprising multiple struts or barsthat provide a tortuous path etc. In another embodiment the cinchingmechanism comprises a knot on one or more tensioning element. Said knotcan be advanced fully tightened or can be loose when advanced andtightened in situ.

FIG. 26N shows a crossectional view of an embodiment of a lockingmechanism comprising a space occupying anchor securely attached to atension element. Locking mechanism 2692 comprises a hollow element 2694comprising a lumen. Hollow element 2694 is a component of a slidinganchor that slides over tension element 2696. Tension element 2696comprises a space occupying anchor 2698 comprising a tapering distal end2699. Anchor 2698 is securely attached to tension element 2696. Diameterof anchor 2698 is larger than the diameter of the lumen of hollowelement. Due to this, anchor 2698 cannot pass through hollow element2694 effectively locking the position of tension element 2696 withrespect to the position of hollow element 2694.

FIGS. 26O and 26P shows a partial sectional view and a perspective viewof an embodiment of a cinching mechanism comprising a punched disk.Cinching mechanism 2602′ comprises a disk 2604′ comprising a punchedhole 2606′. Punched hole 2606′ is made by punching disk 2604′ along theproximal direction such that the punching action leaves an edge that isbiased along the proximal direction as shown in FIG. 26O. Disk 2604′ canslide over a tension element 2608′ along the distal direction. However,motion of disk 2604′ over tension element 2608′ along the proximaldirection is substantially resisted by the proximally biased edges ofpunched hole 2606′.

Excess lengths of tension elements or other severable regions of one ormore devices disclosed in this patent application may be cut, severed ortrimmed using one or more cutting devices. For example, FIGS. 26Q and26R show a perspective view of a first embodiment of a cutting devicebefore and after cutting an elongate element. In FIG. 26Q, cuttingdevice 2610′ comprises an outer sheath 2612′ comprising a sharp distaledge 2614′. Outer sheath 2612′ encloses an inner sheath 2616′. Innerdiameter of outer sheath 2612′ is slightly larger than outer diameter ofinner sheath 2616′ such that inner sheath 2616′ can slide easily throughouter sheath 2612′. Inner sheath 2616′ comprises a lumen that terminatesdistally in an opening 2618′. An elongate severable device passesthrough the lumen and emerges out of opening 2618′. An example of anelongate severable device is a tension element 2620′. In the method ofcutting or trimming tension element 2620′ the desired area of tensionelement 2620′ to be cut or severed is positioned near opening 2618′ byadvancing or withdrawing cutting device 2610′ over tension element2620′. Thereafter, outer sheath 2612′ is advanced over inner sheath2616′ to cut tension element 2620′ between sharp distal edge 2614′ andan edge of opening 2618′. Inner sheath 2616′ and outer sheath 2612′ maybe substantially rigid or flexible. They may be made of suitablematerials including, but not limited to Pebax, Polyimide, BraidedPolyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals likestainless steel and fluoropolymers like PTFE, PFA, FEP and EPTFE etc.

FIG. 26S show a crossectional view of a second embodiment of a cuttingdevice for cutting an elongate element. Cutting device 2622′ comprisesan outer sheath 2624′ comprising a lumen that opens in an opening 2626′in outer sheath 2624′. Outer sheath 2624′ encloses an inner sheath 2628′that comprises a lumen and a sharp distal edge 2630′. Inner diameter ofouter sheath 2624′ is slightly larger than outer diameter of innersheath 2628′ such that inner sheath 2628′ can slide easily through outersheath 2624′. An elongate severable device passes through the lumen ofinner sheath 2628′ and emerges out of distal end of inner sheath 2628′and out of outer sheath 2624′ through opening 2626′. An example of anelongate severable device is a tension element 2632′. In the method ofcutting or trimming tension element 2632′ the desired area of tensionelement 2632′ to be cut or severed is positioned near opening 2626′ byadvancing or withdrawing cutting device 2622′ over tension element2632′. Thereafter, inner sheath 2628′ is advanced through outer sheath2624′ to cut tension element 2632′ between sharp distal edge 2630′ andan edge of opening 2626′. Inner sheath 2628′ and outer sheath 2624 maybe substantially rigid or flexible. They may be made of suitablematerials including, but not limited to Pebax, Polyimide, BraidedPolyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals likestainless steel and fluoropolymers like PTFE, PFA, FEP and EPTFE etc.

In a third embodiment of a cutting device for cutting an elongateelement, the cutting device comprises an outer hollow sheath. Outerhollow sheath has a distal end plate comprising a window. An elongateseverable device passes through the window. An example of an elongateseverable device is a tension element. An inner shaft can slide androtate within outer hollow sheath. Distal end of inner shaft comprises ablade that is usually located away from the window and adjacent to thedistal end plate of the outer hollow sheath. In the method of cutting ortrimming tension element the elongate severable device, the desired areaof the elongate severable device to be cut or severed is positioned nearthe window. This is done by advancing or withdrawing the cutting deviceover the elongate severable device. Thereafter, the inner shaft isrotated within outer hollow sheath such that the blade cuts the elongateseverable device between a sharp edge of the blade and an edge of thewindow. Inner shaft and outer hollow sheath may be substantially rigidor flexible. They may be made of suitable materials including, but notlimited to Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon,PVC, Hytrel, HDPE, PEEK, metals like stainless steel and fluoropolymerslike PTFE, PFA, FEP and EPTFE etc. The end plate and the blade arepreferentially rigid. They may be made of suitable materials including,but not limited to metals like stainless steel, polymers likePolycarbonate, Polyimide, PVC, Hytrel, HDPE, PEEK and fluoropolymerslike PTFE, PFA, FEP etc.

The anchoring devices disclosed herein may be used in a variety ofconfigurations depending on the location of the disease process, ease ofprocedure etc. FIGS. 27A through 27D show axial sections through theprostate gland PG showing various configurations of anchoring devicescomprising distal anchors 2700 and a tension element 2702 that isanchored at a suitable location such that a sufficient tension exists intension element 2702.

FIGS. 28 and 28A show perspective views of an embodiment of an anchoringdevice comprising an elongate element comprising multiple barbs oranchors. FIG. 28 shows a perspective view of anchoring device 2800comprising an elongate element 2802. Elongate element 2802 can be madeof several biocompatible materials including, but not limited tosynthetic fibers e.g. various grades of Nylon, polyethylene,polypropylene, polyester, Aramid etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber etc. Elongate element2802 may comprise natural or artificial suture materials. Examples ofsuch materials include but are not limited to Polyamide (Nylon),Polypropylene, Polyglycolic Acid (PGA), polylactic acid (PLA) andcopolymers of polylactic acid, polyglycolic acid and copolymers ofpolyglycolic acid, copolymers of PLA and PGA, Silk, Polyester, silicone,collagen, Polymers of Glycolide and Lactide. A particular example of asuture is the Nordstrom suture which is a highly elastic siliconesuture. In one embodiment, the suture material is bioabsorbable.Elongate element 2802 comprises two sets of projections such as barbs,anchors or hooks. In the example shown, elongate element 2802 comprisesa set of distal barbs 2804 and a set of proximal barbs 2806. Distalbarbs 2804 are oriented in the proximal direction and proximal barbs2806 are oriented in the distal direction as shown in FIG. 25. FIG. 28Ashows a magnified view of the region 28A of anchoring device 2800showing proximal barbs 2806.

FIGS. 28B through 28E show a coronal section through the prostate glandPG showing various steps of a method of treating the prostate gland PGusing the device of FIG. 28. In FIG. 28B, introducer device 300 of FIG.3A comprising a working device lumen and a cystoscope lumen 308 isintroduced into the urethra such that the distal end of introducerdevice 300 is located in the prostatic urethra. Thereafter, a hollowpuncturing device 2808 is inserted in the working device lumen ofintroducer device. Puncturing device 2808 is advanced such that distalend of puncturing device 2808 penetrates the prostate gland PG. In FIG.28C, anchoring device 2800 is introduced through puncturing device 2808into the prostate gland PG. Thereafter, puncturing device 2808 is pulledin the proximal direction. Simultaneously, anchoring device 2800 ispulled in the proximal direction to anchor distal barbs 2804 in theanatomy. In FIG. 28D, puncturing device 2808 is pulled further in theproximal direction to expose the entire anchoring device 2800.Thereafter, in step 28E, the proximal end of anchoring device 2800 isdetached to deploy anchoring device 2800 in the anatomy. Thus, tissuebetween distal barbs 2804 and proximal barbs 2806 is anchored toanchoring device 2800.

FIG. 29A shows an axial section of the prostate gland PG showing a pairof implanted magnetic anchors. In FIG. 29A, a first magnetic anchor 2900and a second magnetic anchor 2902 are implanted in the prostate gland PGon either side of the urethra. Like poles of first magnetic anchor 2900and second magnetic anchor 2902 face each other such that there ismagnetic repulsion between first magnetic anchor 2900 and secondmagnetic anchor 2902. This causes the urethral lumen to widenpotentially reducing the severity of BPH symptoms.

FIGS. 29B through 29D show a coronal section through the prostate glandPG showing the steps of a method of implanting magnetic anchors of FIG.29A. In FIG. 29B, a deployment device 2904 is advanced transurethrally.Deployment device 2904 comprises a sharp distal tip 2906 and firstmagnetic anchor 2900. Distal tip 2906 of deployment device 2904penetrates prostatic tissue and implants fist magnetic anchor 2900 inthe prostate gland PG. Similarly, another deployment device 2908comprising a sharp distal tip 2920 is used to implant second magneticanchor 2902 in the prostate gland PG. First magnetic anchor 2900 andsecond magnetic anchor 2902 are implanted on opposite sides of theurethra such that like poles of first magnetic anchor 2900 and secondmagnetic anchor 2902 face each other. This causes magnetic repulsionbetween first magnetic anchor 2900 and second magnetic anchor 2902. Thiscauses the urethral lumen to widen potentially reducing the severity ofBPH symptoms. In one embodiment, deployment device 2904 can be used todeploy multiple magnetic anchors.

FIG. 30A shows a coronal section of a region of the male urinary systemshowing the general working environment of a method of treating prostatedisorders by cutting prostate tissue using a device inserted into theprostate gland PG from the urethra. Cutting device 3000 comprises anouter body 3002 comprising a side port 3004. Outer body 3002 can be madeof suitable biocompatible materials including, but not limited to metalse.g. stainless steel, Nickel-Titanium alloys, titanium etc.; polymerse.g. etc. Cutting device 3000 further comprises an access device 3006that can be deployed out of side port 3004. Access device 3006 can beretracted back into side port 3004. Typical examples of elements thatcan be used as access device 3006 are needles, trocars etc. Accessdevice 3006 may be made from suitable biocompatible materials including,but not limited to metals e.g. stainless steel, Nickel-Titanium alloys,titanium etc.; polymers e.g. etc. Access device 3006 penetrates thewalls of the urethra and enters the prostate gland PG by creating anaccess channel in the prostate gland PG. Cutting device 3000 furthercomprises a cutting element 3008 that is introduced into the prostategland PG through the access channel in the prostate gland PG. In oneembodiment, cutting element 3008 enters the prostate gland PG throughaccess device 3006. Cutting element 3008 comprises one or more cuttingmodalities such as electrosurgical cutter, Laser cutter, mechanicalcutter e.g. a knife edge etc. Cutting element 3008 may be moved throughprostate tissue by several mechanisms including one or more deflectingor bending elements located on cutting element 3008; one or morearticulating elements located on cutting element 3008; motion of cuttingdevice 3000 along the urethra etc. Cutting element 3008 is used to cutone or more regions of the prostate gland PG including peripheral zone,transition zone, central zone or prostatic capsule. After the desiredregion or regions of the prostate gland PG are cut, cutting element 3008and access device 3006 are withdrawn into cutting device 3000.Thereafter, cutting device 3000 is withdrawn from the urethra. In onedevice embodiment, cutting device 3000 comprises an endoscope or meansfor inserting an endoscope.

FIG. 30B shows a coronal section of a region of the male urinary systemshowing the general working environment of a method of treating prostatedisorders by cutting prostrate prostate tissue using a device thataccesses outer surface of the prostate gland PG by passing through thewalls of the urethra distal to the prostate gland PG. Cutting device3020 comprises an outer body 3022 comprising a side port 3024. Outerbody 3022 can be made of suitable biocompatible materials including, butnot limited to metals e.g. stainless steel, Nickel-Titanium alloys,titanium etc.; polymers e.g. etc. Cutting device 3020 is advanced intothe urethra such that side port 3024 is located distal to the prostategland PG. Cutting device 3020 further comprises an access device 3026that can be deployed out of side port 3024. Access device 3026 can beretracted back into side port 3024. Typical examples of elements thatcan be used as access device 3026 are needles, trocars etc. Accessdevice 3026 may be made from suitable biocompatible materials including,but not limited to metals e.g. stainless steel, Nickel-Titanium alloys,titanium etc.; polymers e.g. etc. Access device 3026 is deployed fromside port 3024 in a desired orientation such that access device 3026penetrates the wall of the urethra. Access device 3026 is advancedfurther such that distal end of access device 3026 is located near theprostate gland PG. Thereafter, a cutting element 3028 is introducedthrough access device 3026 to the outer surface of the prostate glandPG. Cutting element 3028 comprises one or more cutting modalities suchas electrosurgical cutter, Laser cutter, mechanical cutter e.g. a knifeedge etc. Cutting element 3028 is used to cut one or more regions of theprostate gland PG including prostatic capsule, peripheral zone,transition zone or central zone. Cutting element 3028 may be movedrelative to prostate tissue by several mechanisms including one or moredeflecting or bending elements located on cutting element 3028; motionof cutting element 3028 along access device 3026 etc. In one methodembodiment, cutting element 3028 cuts prostatic capsule while beingwithdrawn into access device 3026. After the desired region or regionsof the prostate gland PG are cut, cutting element 3028 and access device3026 are withdrawn into cutting device 3020. Thereafter, cutting device3020 is withdrawn from the urethra. In one device embodiment, cuttingdevice 3020 further comprises an endoscope or means for inserting anendoscope.

FIG. 30C shows a coronal section of a region of the male urinary systemshowing the general working environment of a method of treating prostatedisorders by cutting prostate tissue using a device that accesses outersurface of the prostate gland PG by passing through the wall of theurinary bladder. Cutting device 3040 comprises an outer body 3042comprising a side port 3044. Outer body 3042 can be made of suitablebiocompatible materials including, but not limited to metals e.g.stainless steel, Nickel-Titanium alloys, titanium etc.; polymers e.g.etc. Cutting device 3040 is advanced into the urethra such that sideport 3044 is located inside the urinary bladder. Cutting device 3040further comprises an access device 3046 that can be deployed out of sideport 3044. Access device 3046 can be retracted back into side port 3044.Typical examples of elements that can be used as access device 3046 areneedles, trocars etc. Access device 3046 may be made from suitablebiocompatible materials including, but not limited to metals e.g.stainless steel, Nickel-Titanium alloys, titanium etc.; polymers e.g.etc. Access device 3046 is deployed from side port 3044 in a desiredorientation such that access device 3046 penetrates the wall of theurinary bladder. Access device 3046 is advanced further such that distalend of access device 3046 is located near the prostate gland PG.Thereafter, a cutting element 3048 is introduced through access device3046 to the outer surface of the prostate gland PG. Cutting element 3048comprises one or more cutting modalities such as electrosurgical cutter,Laser cutter, mechanical cutter e.g. a knife edge etc. Cutting element3048 is used to cut one or more regions of the prostate gland PGincluding prostatic capsule, peripheral zone, transition zone or centralzone. Cutting element 3048 may be moved relative to prostate tissue byseveral mechanisms including one or more deflecting or bending elementslocated on cutting element 3048; motion of cutting element 3048 alongaccess device 3046 etc. In one method embodiment, cutting element 3048cuts prostatic capsule while being withdrawn into access device 3046.After the desired region or regions of the prostate gland PG are cut,cutting element 3048 and access device 3046 are withdrawn into cuttingdevice 3040. Thereafter, cutting device 3040 is withdrawn from theurethra. In one device embodiment, cutting device 3040 further comprisesan endoscope or means for inserting an endoscope.

FIG. 30D shows a coronal section of a region of the male urinary systemshowing the general working environment of a method of treating prostatedisorders by cutting prostate tissue using a device that accesses outersurface of the prostate gland PG by passing through the walls of theurethra enclosed to the prostate gland PG. Cutting device 3060 comprisesan outer body 3062 comprising a side port 3064. Outer body 3062 can bemade of suitable biocompatible materials including, but not limited tometals e.g. stainless steel, Nickel-Titanium alloys, titanium etc.;polymers e.g. etc. Cutting device 3060 is advanced into the urethra suchthat side port 3064 is located in the region of the urethra enclosed bythe prostate gland PG. Cutting device 3060 further comprises an accessdevice 3066 that can be deployed out of side port 3064. Access device3066 can be refracted back into side port 3064. Typical examples ofelements that can be used as access device 3066 are needles, trocarsetc. Access device 3066 may be made from suitable biocompatiblematerials including, but not limited to metals e.g. stainless steel,Nickel-Titanium alloys, titanium etc.; polymers e.g. etc. Access device3066 is deployed from side port 3064 in a desired orientation such thataccess device 3066 penetrates the prostate. Thereafter, a cuttingelement 3068 is introduced through access device 3066 such that thedistal region of cutting element can access the outer surface of theprostate gland PG. Cutting element 3068 comprises one or more cuttingmodalities such as electrosurgical cutter, Laser cutter, mechanicalcutter e.g. a knife edge etc. Cutting element 3068 is used to cut one ormore regions of the prostate gland PG including prostatic capsule,peripheral zone, transition zone or central zone. Cutting element 3068may be moved relative to prostate tissue by several mechanisms includingone or more deflecting or bending elements located on cutting element3068; motion of cutting element 3068 along access device 3066 etc. Inone method embodiment, cutting element 3068 cuts prostatic capsule whilebeing withdrawn into access device 3066. After the desired region orregions of the prostate gland PG are cut, cutting element 3068 andaccess device 3066 are withdrawn into cutting device 3060. Thereafter,cutting device 3060 is withdrawn from the urethra. In one deviceembodiment, cutting device 3060 further comprises an endoscope or meansfor inserting an endoscope.

FIG. 31 shows a coronal section of a region of the male urinary systemshowing the general working environment of a method of treating prostatedisorders by cutting prostate tissue by a percutaneous device thataccesses the prostate gland PG through an incision in the abdomen. Inthis method, a cannula 3100 is introduced percutaneously into the lowerabdomen. Cannula 3100 can be made of suitable biocompatible materialsincluding, but not limited to metals e.g. stainless steel,Nickel-Titanium alloys, titanium etc.; polymers etc. Cannula 3100 isadvanced into the abdomen such that it passes below the pubic bone. Thedistal end of cannula 3100 is positioned near the prostate gland PG.Thereafter, a cutting device 3102 is advanced through distal end ofcannula 3100 to the outer surface of the prostate gland PG. Cuttingdevice 3102 can be retracted back into cannula 3100. Cutting device 3102comprises one or more cutting modalities such as electrosurgical cutter,Laser cutter, mechanical cutter e.g. a knife edge etc. Cutting device3102 is used to cut one or more regions of the prostate gland PGincluding prostatic capsule, peripheral zone, transition zone or centralzone. Cutting device 3102 may be moved relative to prostate tissue byseveral mechanisms including one or more deflecting or bending elementslocated on cutting device 3102; motion of cutting device 3102 alongcannula 3100 etc. In one method embodiment, cutting device 3102 cutsprostatic capsule while being withdrawn into cannula 3100. After thedesired region or regions of the prostate gland PG are cut, cuttingdevice 3102 is withdrawn into cannula 3100. Thereafter, cannula 3100 iswithdrawn from the urethra. In one device embodiment, cannula 3100further comprises an endoscope or means for inserting an endoscope.

FIG. 32 shows a coronal section of a region of the male urinary systemshowing the general working environment of a method of treating prostatedisorders by cutting prostate tissue by a percutaneous device thatpenetrates the urinary bladder and accesses the outer surface of theprostate gland PG through an incision in the urinary bladder. In thismethod, a cannula 3200 is introduced percutaneously into the lowerabdomen. Cannula 3200 can be made of suitable biocompatible materialsincluding, but not limited to metals e.g. stainless steel,Nickel-Titanium alloys, titanium etc.; polymers etc. Cannula 3200 isadvanced into the abdomen such that it passes above the pubic bone. Thedistal end of cannula 3200 enters the urinary bladder. Thereafter, anaccess device 3202 is advanced through cannula 3200 such that accessdevice 3202 penetrates the urinary bladder wall as shown in FIG. 4.Thereafter, a cutting device 3204 is advanced through distal end ofaccess device 3202 to the outer surface of the prostate gland PG.Cutting device 3202 can be retracted back into access device 3202.Cutting device 3202 comprises one or more cutting modalities such aselectrosurgical cutter, Laser cutter, mechanical cutter e.g. a knifeedge etc. Cutting device 3202 is used to cut one or more regions of theprostate gland PG including prostatic capsule, peripheral zone,transition zone or central zone. Cutting device 3202 may be movedrelative to prostate tissue by several mechanisms including one or moredeflecting or bending elements located on cutting device 3202 or accessdevice 3202; motion of cutting device 3202 along access device 3202 etc.In one method embodiment, cutting device 3202 cuts prostatic capsulewhile being withdrawn into access device 3202. After the desired regionor regions of the prostate gland PG are cut, cutting device 3202 iswithdrawn into access device 3202. Access device 3202 is then withdrawninto cannula 3200. Thereafter, cannula 3200 is withdrawn from theurinary bladder. In one device embodiment, cannula 3200 furthercomprises an endoscope or means for inserting an endoscope.

FIG. 33 series shows a perspective view of a prostate treatment kit tocut prostate tissue. FIG. 33A shows a perspective view of an introducerdevice. Introducer device 3300 comprises a first tubular element 3302enclosing a working device lumen 3304. First tubular element 3302 can bemade of suitable biocompatible materials such as Pebax, Polyimide,Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metalslike stainless steel and fluoropolymers like PTFE, PFA, FEP and EPTFEetc. The proximal end of working device lumen 3304 comprises a firststasis valve 3306. The distal end of working device lumen 3304 comprisesa deflection mechanism. The deflection mechanism is used to bend thedistal region of working device lumen 3304. One example of deflectionmechanism is a pull wire and a deflection dial 3310 to adjust themagnitude and/or the direction of deflection caused by the pull wire.Similarly, other deflection mechanisms can be used in the introducerdevice instead of a pull wire. Introducer device 3300 further comprisesa second tubular element 3312 which encloses a cystoscope lumen 3314. Acystoscope can be introduced through cystoscope lumen 3314 into theurethra. Typical examples of cystoscopes that can be used withintroducer device are those manufactured by Olympus, Pentax, Storz,Wolf, Circon-ACMI, etc. These may have pre-set angles (i.e. 0, 30, 70,120 degrees) or may be flexible scopes where in the tip may bedeflectable. The proximal end of cystoscope lumen 3314 comprises asecond stasis valve 3316. The cystoscope is inserted through theproximal end of cystoscope lumen 3314 and emerges out into the urethrafrom the distal end of cystoscope lumen 3314. The cystoscope can then beused to visualize the anatomy and various instruments during aprocedure. Working device lumen 3314 may comprise one or more side portse.g. a first side port 3318 for the introduction or removal of one ormore fluids. Cystoscope lumen 3314 may comprise one or more side portse.g. a second side port 3320 for the introduction or removal of one ormore fluids.

FIG. 33B shows a perspective view of an injecting needle. Injectingneedle 3330 is used for injecting one or more diagnostic or therapeuticagents in the anatomy. In one method embodiment, injecting needle 3330is used to inject local anesthetic in the urethra and/or prostate glandPG. Specific examples of target areas for injecting local anestheticsare the neurovascular bundles, the genitourinary diaphragm, the regionbetween the rectal wall and prostate, etc. Examples of local anestheticsthat can be injected by injecting needle 3330 are anesthetic solutionse.g. 1% lidocaine solution; anesthetic gels e.g. lidocaine gels;combination of anesthetic agents e.g. combination of lidocaine andbupivacaine; etc. Injecting needle 3330 comprises a hollow shaft 3332made of suitable biocompatible materials including, but not limited tostainless steel 304, stainless steel 306, Nickel-Titanium alloys,titanium etc. The length of hollow shaft 3332 can range from tocentimeters. The distal end of hollow shaft 3332 comprises a sharp tip3334. The proximal end of hollow shaft 3332 has a needle hub 3336 madeof suitable biocompatible materials including, but not limited to metalse.g. like stainless steel 304, stainless steel 306, Nickel-Titaniumalloys, titanium etc.; polymers e.g. polypropylene etc. In oneembodiment, needle hub 3336 comprises a luer lock.

FIG. 33C shows a perspective view of a guiding device. Guiding device3338 comprises an elongate body 3340 comprising a sharp distal tip 3342.In one embodiment, guiding device 3338 is a guidewire. Distal end ofelongate body 3340 may comprise an anchoring element to reversiblyanchor guiding device 3338 into tissue. Examples of suitable anchoringelements are barbs, multipronged arrowheads, balloons, othermechanically actuable members (e.g. bendable struts), screw tips, shapememory elements, or other suitable anchor designs disclosed elsewhere inthis patent application.

FIG. 33D shows a perspective view of a RF cutting device. Cutting device3343 comprises an inner sheath 3344 and an outer sheath 3346. Innersheath 3344 comprises a lumen of a suitable dimension such that cuttingdevice 3343 can be advanced over guiding device 538. Outer sheath 3346can slide on inner sheath 3344. Outer sheath 3346 also comprises twomarker bands: a proximal marker band 3348 and a distal marker band 3350.The marker bands can be seen by a cystoscope. In one embodiment,proximal marker band 3348 and distal marker band 3350 are radiopaque.The position of proximal marker band 3348 and distal marker band 3350 issuch that after cutting device 3343 is placed in an optimum location inthe anatomy, proximal marker band 3348 is located in the urethra whereit can be seen by a cystoscope and distal marker band 3350 is located inthe prostate gland PG or in the wall of the urethra where it cannot beseen by the cystoscope. Cutting device 3343 further comprises a cuttingwire 3352 that is capable of delivering electrical energy to thesurrounding tissue. The distal end of cutting wire 3352 is fixed to thedistal region of outer sheath 3344. The proximal end of cutting wire3352 is connected to a distal region of outer sheath 3346 and is furtherconnected to a source of electrical energy. In FIG. 33D, cutting wire3352 is in an undeployed configuration. FIG. 33D′ shows the distalregion of cutting device 3343 when cutting wire 3352 is in a deployedconfiguration. To deploy cutting wire 3352, inner sheath 3344 is movedin the proximal direction with respect to outer sheath 546. This causescutting wire 3352 to bend axially outward thus deploying cutting wire3352 in the surrounding anatomy.

FIG. 33E shows a perspective view of an embodiment of a plugging deviceto plug an opening created during a procedure. Plugging device 3354comprises a tubular shaft 3356 comprising a distal opening 3358. Distalopening 3358 is used to deliver one or more plugging materials 3360 inthe adjacent anatomy. Plugging material 3360 may comprise a porous ornon-porous matrix formed of a biodegradable or non-biodegradablematerial such as a flexible or rigid polymer foam, cotton wadding,gauze, hydrogels, etc. Examples of biodegradable polymers that may befoamed or otherwise rendered porous include but are not restricted topolyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids),polydioxanone, polycaprolactone, polygluconate, polylacticacid-polyethylene oxide copolymers, modified cellulose, collagen,polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester,poly(alpha-hydroxy acid) and combinations thereof. In one embodiment,plugging material 3360 comprises biocompatible sealants including butnot limited to fibrin sealants, combination of natural proteins (e.g.collagen, albumin etc.) with aldehyde cross-linking agents (e.g.glutaraldehyde, formaldehyde) or other polymeric, biological ornon-polymeric materials capable of being implanted with the body, etc.Plugging device 3354 may be introduced in the anatomy by variousapproaches including the approaches disclosed elsewhere in this patentapplication. Plugging device 3354 may be introduced in the anatomythrough a cannula, over a guiding device such as a guidewire etc. In theembodiment shown in FIG. 33E, plugging material 3360 is preloaded inplugging device 3354. Plugging material 3360 is introduced throughdistal opening 3358 by pushing plunger 3362 in the distal direction. Inanother embodiment, plugging device 3354 comprises a lumen that extendsfrom the proximal end to distal opening 3358. Plugging material 3360 maybe injected through the proximal end of the lumen such that it emergesout through distal opening 3358.

FIGS. 33F through 33N show various alternate embodiments of theelectrosurgical cutting device in FIG. 33D. FIGS. 33F and 33G showperspective views of the distal region of a first alternate embodimentof an electrosurgical cutting device in the undeployed and deployedstates respectively. FIG. 33F show an electrosurgical cutting device 570comprising an elongate shaft 3372. Shaft 3372 is made of an electricallyinsulating material. Electrosurgical cutting device 3370 furthercomprises an electrosurgical cutting wire 3374. Electrosurgical cuttingwire 3374 can be made of a variety of materials including, but notlimited to tungsten, stainless steel, etc. Distal end of cutting wire3374 is attached to distal region of shaft 3372. The proximal region ofcutting wire 3374 can be pulled in the proximal direction by anoperator. In one embodiment, electrosurgical cutting device 3370 isintroduced in the target anatomy through a sheath 3376. In FIG. 33F,electrosurgical cutting device 3370 is deployed by pulling cutting wire3374 in the proximal direction. This causes distal region of shaft 3372to bend. Thereafter, electrical energy is delivered through cutting wire3374 to cut tissue. This may be accompanied by motion of electrosurgicalcutting device 3370 along the proximal or distal direction.

FIGS. 33H and 33I show perspective views of the distal region of asecond alternate embodiment of an electrosurgical cutting device in theundeployed and deployed states respectively. Electrosurgical cuttingdevice 3380 comprises an elongate sheath 3382 comprising a lumen. Distalregion of sheath 3382 has a window 3384. Electrosurgical cutting device3380 further comprises an electrosurgical cutting wire 3386 located inthe lumen. Distal end of cutting wire 3386 is fixed to the distal end ofsheath 3384. Proximal end of cutting wire 3386 can be pushed in thedistal direction by a user. In FIG. 33I, cutting wire 3386 is deployedby pushing cutting wire 3386 in the distal direction. This causes aregion of cutting wire 3386 to bend in the radially outward directionand thus emerge out of window 3384. Thereafter, electrical energy isdelivered through cutting wire 3386 to cut tissue. This may beaccompanied by motion of electrosurgical cutting device 3380 along theproximal or distal direction.

FIGS. 33J through 33L show perspective views of the distal region of asecond alternate embodiment of an electrosurgical cutting device showingthe steps of deploying the electrosurgical cutting device.Electrosurgical cutting device 3390 comprises an elongate sheath 3391comprising a lumen 3392. In FIG. 33J, an electrosurgical cutting wire3394 is introduced through lumen 3392 such that it emerges out throughthe distal opening of lumen 3392. In FIG. 33K, cutting wire 3394 isfurther advanced in the distal direction. Distal end of cutting wire3394 has a curved region so that cutting wire 3394 starts to bend as itemerges out of lumen 3392. IN FIG. 33L, cutting wire 3394 is furtheradvanced in the distal direction to fully deploy cutting wire 3394.Thereafter, electrical energy is delivered through cutting wire 3394 tocut tissue. This may be accompanied by motion of electrosurgical cuttingdevice 3390 along the proximal or distal direction.

FIGS. 33M through 33N show perspective views of the distal region of athird alternate embodiment of an electrosurgical cutting device showingthe steps of deploying the electrosurgical cutting device.Electrosurgical cutting device 3395 comprises an elongate sheath 3396comprising a lumen. Cutting device 3395 further comprises a cutting wire3398 located in the lumen of elongate sheath 3396. The proximal end ofcutting wire 3398 is connected to a source of electrical energy. Distalend of cutting wire 3398 is connected to the inner surface of the distalregion of elongate sheath 3396. Cutting wire 3398 may be made fromsuitable elastic, super-elastic or shape memory materials including butnot limited to Nitinol, titanium, stainless steel etc. In FIG. 33N,Electrosurgical cutting device 3395 is deployed by pushing the proximalregion of cutting wire 3398 in the distal direction. This causes adistal region of cutting wire 3398 to emerge from the distal end ofelongate sheath 3396 as a loop. Thereafter, electrical energy isdelivered through cutting wire 3398 to cut tissue. This may beaccompanied by motion of electrosurgical cutting device 3395 along theproximal or distal direction. Electrosurgical cutting device 3395 can beused to cut multiple planes of tissue by withdrawing cutting wire 3398in elongate sheath 3396, rotating elongate sheath 3396 to a neworientation, redeploying cutting wire 3398 and delivering electricalenergy through cutting wire 3398. The devices 33H through 33N may beintroduced by one or more access devices such as guidewires, sheathsetc.

FIG. 34 shows a perspective view of the distal region of a ballooncatheter comprising a balloon with cutting blades. Balloon catheter 3400can be introduced into a lumen or in the tissue of an organ to betreated using one or more of the introducing methods disclosed elsewherein this patent application. Balloon catheter 3400 comprises a shaft3402. Shaft 3402 may comprise a lumen to allow balloon catheter 3400 tobe introduced over a guidewire. In one embodiment, shaft 3402 istorquable. Shaft 3402 comprises a balloon 3404 located on the distal endof shaft 3402. Balloon 3404 can be fabricated from materials including,but not limited to polyethylene terephthalate, Nylon, polyurethane,polyvinyl chloride, crosslinked polyethylene, polyolefins, HPTFE, HPE,HDPE, LDPE, EPTFE, block copolymers, latex and silicone. Balloon 3404further comprises one or more cutter blades 3406. Balloon catheter 3400is advanced with balloon 3404 deflated, into a natural or surgicallycreated passageway and positioned adjacent to tissue or matter that isto be cut, dilated, or expanded. Thereafter, balloon 3404 is inflated tocause cutter blades 3406 to make one or more cuts in the adjacent tissueor matter. Thereafter balloon 3404 is deflated and balloon catheter 3400is removed. Cutter blades 3406 may be energized with mono or bi-polar RFenergy. Balloon catheter 3400 may comprise one or more navigationmarkers including, but not limited to radio-opaque markers, ultrasoundmarkers, light source that can be detected visually etc.

FIG. 35 shows a perspective view of the distal region of a ballooncatheter comprising a balloon with cutting wires. Balloon catheter 3500can be introduced into a lumen or in the tissue of an organ to betreated using one or more of the introducing methods disclosed elsewherein this patent application. Balloon catheter 3500 comprises a shaft3502. Shaft 3502 may comprise a lumen to allow balloon catheter 3500 tobe introduced over a guidewire. In one embodiment, shaft 3502 istorquable. Shaft 3502 comprises a balloon 3504 located on the distal endof shaft 3502. Balloon 3504 can be fabricated from materials including,but not limited to polyethylene terephthalate, Nylon, polyurethane,polyvinyl chloride, crosslinked polyethylene, polyolefins, HPTFE, HPE,HDPE, LDPE, EPTFE, block copolymers, latex and silicone. Balloon 3504further comprises one or more radiofrequency wires 3506. Ballooncatheter 3500 is advanced with balloon 3504 deflated, into a natural orsurgically created passageway and positioned adjacent to tissue ormatter that is to be cut, dilated, or expanded. Thereafter, balloon 3504is inflated and an electrical current is delivered throughradiofrequency wires 3506 to make one or more cuts in the adjacenttissue or matter. Thereafter the electrical current is stopped, balloon3504 is deflated and balloon catheter 3500 is removed. Radiofrequencywires 3504 may be energized with mono or bi-polar RF energy. Ballooncatheter 3500 may comprise one or more navigation markers including, butnot limited to radio-opaque markers, ultrasound markers, light sourcethat can be detected visually etc.

FIGS. 36A and 36B series show perspective views of an undeployed stateand a deployed state respectively of a tissue displacement device. FIG.36A shows a tissue anchoring device 3600 in the undeployed state.Anchoring device 3600 comprises an elongate body having a proximal end3602 and a distal end 3604. Anchoring device 3600 may be made of avariety of elastic or super-elastic materials including, but not limitedto Nitinol, stainless steel, titanium etc. Anchoring device 3600 issubstantially straight in the undeployed state and has a tendency tobecome substantially curved in the deployed state. Anchoring device 3600is maintained in the undeployed state by a variety of means including,but not limited to enclosing anchoring device 3600 in a cannula orsheath, etc. FIG. 36B shows tissue anchoring device 3600 in the deployedstate. Anchoring device 3600 comprises a curved region. When anchoringdevice 3600 changes from an undeployed state to a deployed state, theanatomical tissue adjacent to the central region of anchoring device3600 is displaced along the direction of motion of the central region.Anchoring device 3600 can be deployed by a variety of methods including,but not limited to removing anchoring device 3600 from a sheath orcannula, etc. In one embodiment, anchoring device 3600 is made from ashape memory material such as Nitinol. In this embodiment, anchoringdevice 3600 is maintained in the undeployed state by maintaining anchordevice 3600 in a temperature lower than the transition temperature ofthe super-elastic material. Anchoring device 3600 is converted to thedeployed state by implanting anchoring device 3600 in a patient suchthat the device is warmed to the body temperature which is above thetransition temperature of the super-elastic material.

FIGS. 36C and 36D show a coronal view and a lateral view respectively ofa pair of deployed tissue displacement devices of FIGS. 36A and 36Bimplanted in the prostate gland PG. In FIG. 36C, two anchoring devicesare implanted in the prostate gland PG near the prostatic urethra in apatient with BPH. A first anchoring device 3600 is introduced on a firstside of the urethra and is deployed there as shown. Similarly, a secondanchoring device 3606 comprising a proximal end 3608 and a distal end3610 is introduced on the other side of the urethra and is deployedthere as shown. First anchoring device 3600 and second anchoring device3606 change into the deployed curved configuration. This causes prostategland PG tissue near the central regions of first anchoring device 3600and second anchoring device 3606 to be displaced radially away from theurethra. This displacement of prostate gland PG tissue can be used toeliminate or reduce the compression of the urethra by an enlargedprostate gland PG. FIG. 36D shows a lateral view of the urethra enclosedby the prostate gland PG showing deployed first anchoring device 3600and second anchoring device 3606.

The various cuts or punctures made by one or more cutting devicesdisclosed in this patent application may be plugged or lined by aplugging or space filling substance. FIGS. 36E through 36H show an axialsection through a prostate gland showing the various steps of a methodof cutting or puncturing the prostate gland and lining or plugging thecut or puncture. FIG. 36E shows a section of the prostate gland showingthe urethra, the lateral lobes and the middle lobe surrounded by theprostatic pseudocapsule. In FIG. 36F, one or more cuts are made in aregion of the prostatic pseudocapsule. In addition, one or more cuts maybe made in a region of between two lobes of the prostate gland. In FIG.36G, a plugging material 3619 is introduced in the one or more regionsof the prostate gland that are cut or punctured. Plugging material 3619may be delivered through one or more delivery devices including, but notlimited to the device disclosed in FIG. 33E. Plugging material 3619 maycomprises a material such as plugging material 3360.

The various cuts or punctures made by one or more cutting devicesdisclosed in this patent application may be spread open by a clippingdevice. For example, FIG. 36H shows an axial section through a prostategland showing a clip for spreading open a cut or punctured region of theprostate gland. Spreading device 3620 comprises a body having a centralregion and two distal arms. Spreading device 3620 may be made of avariety of elastic or super-elastic materials including, but not limitedto Nitinol, stainless steel, titanium etc. Spreading device 3620 has areduced profile in the undeployed state by maintaining distal arms closeto each other. Spreading device 5000 is maintained in the undeployedstate by a variety of means including, but not limited to enclosingspreading device 3620 in a cannula or sheath, etc. When spreading device3620 changes from an undeployed state to a deployed state, the distancebetween the two distal arms increases. This causes any anatomical tissuebetween two distal arms to spread along the straight line between twodistal arms Spreading device 3620 can be deployed by a variety ofmethods including, but not limited to removing spreading device 3620from a sheath or cannula, etc. In one embodiment, spreading device 3620is made from a shape memory material such as Nitinol. In thisembodiment, spreading device 3620 is maintained in the undeployed stateby maintaining anchor device 3620 in a temperature lower than thetransition temperature of the super-elastic material. Spreading device3620 is converted to the deployed state by implanting spreading device3620 in a patient such that the device is warmed to the body temperaturewhich is above the transition temperature of the super-elastic material.Stretching of prostate gland tissue can be used to eliminate or reducethe compression of the urethra by an enlarged prostate gland or toprevent cut edges of a cut from rejoining.

More than one spreading device 3620 may be used to treat the effects ofan enlarged prostate or to eliminate or reduce the compression of theurethra by an enlarged prostate gland or to prevent cut edges of a cutfrom rejoining.

FIGS. 37A through 37K show an embodiment of a method of treatingprostate gland disorders by cutting a region of the prostate gland usingthe devices described in FIG. 33A through 33E. In FIG. 37A, introducerdevice 3300 is introduced in the urethra. It is advanced through theurethra such that the distal tip of introducer device 3300 is located inthe prostatic urethra. Thereafter, injecting needle 3330 is introducedthrough introducer device 3300. The distal tip of injecting needle 3330is advanced such that injecting needle 3330 penetrates the prostategland. Injecting needle 3330 is then used to inject a substance such asan anesthetic in the prostate gland. Thereafter, in FIG. 37B, injectingneedle 3330 is withdrawn from the anatomy. The distal region ofintroducer device 3300 is positioned near a region of the prostate glandto be punctured. Thereafter, in FIG. 37C, first tubular element 3302 isbent or deflected with a bending or deflecting mechanism such as thebending mechanism in FIGS. 37C″ and 37C′″ to align the distal region offirst tubular element 3302 along a desired trajectory of puncturing theprostate gland.

FIG. 37C′ shows the proximal region of introducer device 3300. Acystoscope 3700 is introduced through second stasis valve 3316 such thatthe distal end of cystoscope 3700 emerges through the distal end ofintroducer device 3300. Cystoscope 3700 is then used to visualize theanatomy to facilitate the method of treating prostate gland disorders.

FIG. 37C″ shows a perspective view of the distal region of an embodimentof introducer device 3300 comprising a bending or deflecting mechanism.In this embodiment, first tubular element 3302 comprises a spiral cutdistal end and a pull wire. In FIG. 37C′″, the pull wire is pulled bydeflection dial 3310. This deflects the distal tip of first tubularelement 3302 as shown.

After the step in FIG. 37C, guiding device 3338 is introduced throughfirst tubular element 3302. Guiding device 3338 is advanced throughfirst tubular element 3302 such that the distal tip of guiding device3338 penetrates into the prostate gland. In one method embodiment,guiding device 3338 is further advanced such that the distal tip ofguiding device 3338 penetrates through the prostate gland and enters theurinary bladder. In one embodiment, distal region of guiding device 3338comprises an anchoring element 3702. Anchoring element 3702 is deployedas shown in FIG. 37E. Thereafter, guiding device 3338 is pulled in theproximal direction till anchoring element 3702 is snug against the wallof the urinary bladder. Cystoscope 3700 can be used to visualize thesteps of penetrating the prostate gland by guiding device 3338 anddeploying anchoring element 3702. If guiding device 3338 is notpositioned in a satisfactory position, guiding device 3338 is pulledback in introducer device 3300. The deflection angle of distal end offirst tubular lumen 3302 is changed and guiding device 3338 isre-advanced into the urinary bladder. FIG. 37E′ shows a perspective viewof an embodiment of anchoring element 3702. Anchoring element comprisesa hollow sheath 3704. Distal region of hollow sheath 3704 is attached todistal region of guiding device 3338. A number of windows are cut in thedistal region of hollow sheath 3704 such that several thin, splayablestrips are formed between adjacent windows. Pushing hollow sheath 3704in the distal direction causes splayable strips to splay in the radiallyoutward direction to form an anchoring element. In FIG. 37F, cuttingdevice 3343 is advanced over guiding device 3338 into the prostategland. In FIG. 37G, cutting device 3343 is positioned in the prostategland such that proximal marker band 3348 can be seen by cystoscope 3700but distal marker band 3350 cannot be seen.

Thereafter, in FIG. 37H, relative motion between outer sheath 3343 andinner sheath 3344 causes cutting wire 3352 to deploy outward in theaxial direction. In one embodiment, this step is carried out by movingouter sheath 3343 in the distal direction while the inner sheath 3344 isstationary. In another embodiment, this step is carried out by movinginner sheath 3344 in the proximal direction while outer sheath 3343 iskept stationary. Also during step, electrical energy is deliveredthrough cutting wire 3352 to cut tissue. In FIG. 37I, cutting device3343 is pulled in the proximal direction such that the deployed cuttingwire 3352 slices through tissue. Thereafter, cutting wire 3352 iswithdrawn again in cutting device 3343. Cutting device 3343 is thenremoved from the anatomy.

In FIG. 37J, plugging device 3354 is introduced over guiding device 3338through the puncture or opening in the prostate gland. Thereafter, inFIG. 37K, anchoring element 3702 is undeployed and guiding device 3343is withdrawn from the anatomy. Thereafter, plugging device 3354 is usedto deliver one or more plugging materials in the adjacent anatomy. Theplugging materials can be used to plug or line some or all of the cutsor punctures created during the method.

FIGS. 38A to 38D show various components of a kit for treating prostategland disorders by compressing a region of the prostate gland. FIG. 38Ashows the perspective view of an introducer device 3800. Introducerdevice 3800 comprises an outer body 3801 constructed from suitablebiocompatible materials including, but not limited to metals likestainless steel, Nichol plated brass, polymers like Pebax, Polyimide,Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK andfluoropolymers like PTFE, PFA, FEP, EPTFE etc. Body 3801 comprises aworking device lumen 3802. Distal end of working device lumen 3802emerges out of the distal end of body 3801. Proximal end of workingdevice lumen 3802 incorporates lock thread 3803 such that introducerdevice may join with other devices. Device lumen 3802 may comprise oneor more side ports e.g. a first side port 3804 and a second side port3805 for the introduction or removal of one or more fluids.

FIG. 38B shows a perspective view of a bridge device 3806 constructedfrom suitable biocompatible materials including, but not limited tometals like stainless steel, Nichol plated brass, polymers like Pebax,Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE,PEEK and fluoropolymers like PTFE, PFA, FEP, EPTFE etc. Bridge devicemay insert into introducer lumen 3802 and lock into place by threadablymating thread lock 3807 with thread 3803. Bridge may incorporate port3808 for cystoscope with locking means 3809 that joins to cystoscopewhen inserted. Bridge device may incorporate one or more working lumens.Working lumen 3810 emerges out of the distal end of body 3806. In oneembodiment, distal end of working device lumen 3810 has a bent or curvedregion. Proximal end of lumen 3810 emerges from port 3811 that mayincorporate fluid stasis valve 3812 and a luer lock. Working lumen 3813emerges distally in straight fashion through blunt obturator 3814 atdistal end of body 3806 and emerges proximally through second port thatmay incorporate fluid stasis valve and luer lock.

FIG. 38C shows a perspective view of a distal anchor deployment device3815 constructed from suitable biocompatible materials including, butnot limited to polymers like Polycarbonate, PVC, Pebax, Polyimide,Braided Pebax, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals likestainless steel, Nichol plated brass, and fluoropolymers like PTFE, PFA,FEP, EPTFE etc. Deployment device 3815 comprises handle 3816, whichincorporates movable thumb ring pusher 3817 and anchor deployment latch3818; and distal shaft 3819 which has trocar point 3820 at distal end.Mounted on distal shaft 3819 is distal anchor 3821 that incorporatestether 3822. Tether 3822 can be made of suitable elastic or non-elasticmaterials including, but not limited to metals e.g. stainless steel 304,stainless steel 306, Nickel-Titanium alloys, suture materials, titaniumetc. or polymers such as silicone, nylon, polyamide, polyglycolic acid,polypropylene, Pebax, PTFE, ePTFE, silk, gut, or any other monofilamentor any braided or mono-filament material. Proximal end of tether 3822may incorporate hypotube 3823. Distal anchor 3821 is constructed fromsuitable biocompatible materials including, but not limited to metalse.g. stainless steel 304, stainless steel 306, Nickel-Titanium alloys,titanium etc. or polymers e.g. Pebax, Braided Pebax, Polyimide, BraidedPolyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP,EPTFE etc. Deployment device 3815 is inserted into bridge working lumen3810. Advancement of thumb ring 3817 extends distal shaft 3819 throughdistal end of working lumen 3810, preferably into tissue for deploymentof distal anchor 3821. Depth of distal shaft deployment can be monitoredon cystoscope by visualizing depth markers 3824. Once distal shaft 3819is deployed to desired depth, anchor deployment latch 3818 is rotated torelease distal anchor 3821. Retraction of thumb ring 3817 then retractsdistal shaft 3819 while leaving distal anchor 3821 in tissue. Bridge3806 is then disconnected from introducer device 3800 and removed.

FIG. 38D shows the proximal anchor delivery tool 3825 constructed fromsuitable biocompatible materials including, but not limited to polymerslike Polycarbonate, PVC, Pebax, Polyimide, Braided Pebax, Polyurethane,Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainless steel, Nicholplated brass, and fluoropolymers like PTFE, PFA, FEP, EPTFE etc.Proximal anchor delivery tool 3825 comprises handle 3826, whichincorporates anchor deployment switch 3827 in slot 3828 and tether cutswitch 3829; and distal shaft 3830 which houses hypotube 3831. Lumen ofhypotube 3831 emerges proximally at port 3832 which may incorporate aluer lock. Mounted on the hypotube and distal shaft is the proximalanchor 3833 with cinching hub 3834. Proximal anchor 3833 is constructedfrom suitable biocompatible materials including, but not limited tometals e.g. stainless steel 304, stainless steel 306, Nickel-Titaniumalloys, titanium etc. or polymers e.g. Pebax, Braided Pebax, Polyimide,Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE,PFA, FEP, EPTFE or biodegradable polymers e.g. polyglycolic acid,poly(dioxanone), poly(trimethylene carbonate) copolymers, andpoly(ε-caprolactone) homopolymers and copolymers etc. FIG. 38E shows aclose-up perspective view of proximal anchor 3833 mounted on hypotube3831 and distal shaft 3830 of proximal anchor delivery tool 3825.Hypotube 3831 biases open the cinching lock 3835 of cinching hub 3834.In order to deploy proximal anchor 3833, hypotube 3823 is loaded intohypotube 3831 until it exits proximal port 3832. Hypotube 3823 is thenstabilized while proximal anchor delivery tool 3825 is advanced intointroducer device lumen 3802 and advanced to tissue target. Becausehypotube 3831 biases open cinching lock 3835, the proximal anchordelivery tool travels freely along tether 3822. Once proximal anchor3833 is adequately apposed to urethral wall of prostate, anchordeployment switch 3827 is retracted. During retraction of switch 3827,hypotube 3831 is retracted proximal to cinching hub 3834 and tether 3822is tightened. When switch 3827 is fully retracted or desired tension isaccomplished, tether 3822 is cut within cinching hub 3834 by advancingcutting switch 3829.

Any of the anchoring devices disclosed herein may comprise one or moresharp distal tips, barbs, hooks etc. to attach to tissue.

Various types of endoscopes can be used in conjunction with the devicesdisclosed herein such as flexible scopes that are thin, flexible,fibre-optic endoscopes and rigid scopes that are thin, solid, straightendoscopes. The scopes may have one or more side channels for insertionof various instruments. Further they may be used with in conjunctionwith standard and modified sheaths intended for endoscopic andtransurethral use.

Local or general anesthesia may be used while performing the proceduresdisclosed herein. Examples of local anesthetics that can be used areanesthetic gels e.g. lidocaine gels in the urethra; combination ofanesthetic agents e.g. combination of lidocaine and bupivacaine in theurethra; spinal anesthetics e.g. ropivacaine, fentanyl etc.; injectableanesthetics e.g. 1% lidocaine solution injected into the neurovascularbundles, the genitourinary diaphragm, and between the rectal wall andprostate; etc.

An optional trans-rectal ultrasound exam may be performed before and/orduring the procedures disclosed herein. In this exam, a device calledultrasound transducer is inserted into the rectum. The ultrasoundtransducer is then used to image the prostate gland PG using ultrasoundwaves. The devices may be modified so that they are more visible underultrasound such as etched surfaces. Other imaging devices may also beoptionally used such as MRI, RF, electromagnetic and fluoroscopic orX-ray guidance. The anchoring devices or delivery devices may containsensors or transmitters so that certain elements may be tracked andlocated within the body. The tethering devices may be used as cables totemporarily transmit energy to the distal and/or proximal anchors duringdeployment.

The invention has been described hereabove with reference to certainexamples or embodiments of the invention but various additions,deletions, alterations and modifications may be made to those examplesand embodiments without departing from the intended spirit and scope ofthe invention. For example, any element or attribute of one embodimentor example may be incorporated into or used with another embodiment orexample, unless to do so would render the embodiment or exampleunsuitable for its intended use. Also, where the steps of a method orprocess are described, listed or claimed in a particular order, suchsteps may be performed in any other order unless to do so would renderthe embodiment or example un-novel, obvious to a person of ordinaryskill in the relevant art or unsuitable for its intended use. Allreasonable additions, deletions, modifications and alterations are to beconsidered equivalents of the described examples and embodiments and areto be included within the scope of the following claims.

What is claimed is:
 1. A system for altering the crossectionalmorphology of a lumen within the body of a human or animal subject, saidsystem comprising: an introduction device positionable within the lumen,the introduction device including a working device lumen having a lumenopening emerging from the introduction device, the working device lumenhaving a fixed, longitudinally curved lumen communicating with theworking device lumen opening to establish a predefined angle transverseto a longitudinal axis of the introduction device; an extendable memberprojecting from the introduction device proximal from a terminal end ofthe introduction device through the fixed curve lumen and working devicelumen opening at the angle of the predefined angle transverse to alongitudinal axis of the introduction device; a permanently implantabledevice that is introduceable through the introduction device into anopening in the lumen, said device being useable to modify the forcesexerted on the lumen by tissue outside of the lumen, thereby resultingin a change of the crossectional morphology of the lumen.
 2. A systemaccording to claim 1 wherein the lumen within the body comprises theurethra and the device modifies forces exerted by the prostate gland onthe urethra.
 3. A system according to claim 1 wherein the lumen withinthe body comprises a blood vessel and the device modifies forces exertedon the blood vessel by tissue adjacent thereto.
 4. A system according toclaim 1 wherein the lumen within the body comprises a lumen of thetrachea, bronchus, bronchiole or other respiratory passageway and thedevice modifies forces exerted on that trachea, bronchus, bronchiole orother respiratory passageway by tissue adjacent thereto.
 5. A systemaccording to claim 1 wherein the lumen within the body comprises a lumenof the stomach, duodenum, small intestine, jejunum, illium, colon,cystic duct, hepatic duct, common bile duct, pancreatic duct or otheralimentary or endocrine passageway and the device modifies forcesexerted on that trachea, stomach, duodenum, small intestine, jejunum,illium, colon, cystic duct, hepatic duct, common bile duct, pancreaticduct or other alimentary or endocrine passageway by tissue adjacentthereto.
 6. A system according to claim 1 wherein the lumen within thebody comprises a lumen of a lymphatic passageway and the device modifiesforces exerted on that lymphatic passageway by tissue adjacent thereto.7. A system according to claim 1 wherein the tissue comprises an organ.8. A system according to claim 1 wherein the tissue comprises aneoplasm, benign growth, cancerous growth, tumor, cyst or other mass. 9.A system according to claim 1 wherein the tissue comprises congenitaldeformity.
 10. A system according to claim 1 wherein the tissuecomprises an anatomical structure that has become enlarged due tohypertrophy, hyperplasia, edema, fluid build up, fluid retention, excessfluid production, impeded fluid outflow, a tumor.
 11. A system accordingto claim 1 wherein the curved portion is a distal portion of the workingdevice lumen of the introduction device.
 12. A system according to claim11 wherein the extendable member is a needle.
 13. A system according toclaim 11 further comprising a trocar sized to be translatable within theintroduction device.
 14. A system according to claim 11 furthercomprising an anchor delivery device sized to be received by theintroduction device.
 15. A system according to claim 11 wherein theintroduction device includes the working device lumen and a secondlumen.
 16. A system according to claim 15 wherein the working devicelumen includes the curved portion.
 17. A system according to claim 16further comprising a cystoscope and wherein the second lumen is sized toreceive the cystoscope.